Effect of Contact Lens Solutions in Stabilizing the Activity of Tear Lysozyme.

Purpose: Interactions between tear proteins and the interfaces of contact lenses can be complex and can influence contact lens wear success. Tear proteins, including lysozyme, function to maintain the balance of ocular surface homeostasis, as evidenced by the effects of its conformation relative to stabilizing the tear film and its potential impact on corneal epithelial cells. Contact lens manufacturers include components in lens care and blister package solutions to help stabilize the tear film and preserve homeostasis. This in vitro study was performed to evaluate the ability of daily disposable contact lens package solutions to stabilize lysozyme and preserve its native conformation under denaturing conditions. Methods: Lysozyme was added to contact lens solutions sampled from kalifilcon A, etafilcon A, senofilcon A, narafilcon A, nelfilcon A, verofilcon A, delefilcon A, somofilcon A, and stenfilcon A blister packages, then mixed with the protein denaturant sodium lauryl sulfate. Lysozyme activity was evaluated by adding test solutions to a suspension of Micrococcus luteus. Native lysozyme lyses the Micrococcus luteus cell wall, which decreases suspension turbidity. Stabilization of lysozyme activity was determined by comparing suspension turbidity before and after exposure to test solutions. Results: Lysozyme stabilization was 90.7% for kalifilcon A solution, a statistically significant improvement (p < 0.05) compared to phosphate buffered saline (PBS, negative control). No significant improvement was observed with any other contact lens solution (all lysozyme stabilization < 5.00%). Conclusion: The representative tear protein lysozyme was significantly more stable in the novel kalifilcon A contact lens solution containing multiple moisturizers and osmoprotectants than in PBS or other daily disposable contact lens solutions. The lysozyme activity assay provides mechanistic evidence that the kalifilcon A contact lens solution can stabilize proteins under conditions that typically denature proteins, which may contribute to maintaining ocular surface homeostasis.

Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis.

PURPOSE: The objective of this study was to evaluate and compare the clinical performance of samfilcon A, a unique, polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens with that of the balafilcon A silicone hydrogel contact lens when worn on a 7-day extended wear basis. SUBJECTS AND METHODS: A total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses. Subjects wore their respective assigned lenses bilaterally on a 7-day extended wear basis. On the seventh night of each wearing week, lenses were removed, cleaned, and disinfected using Biotrue multi-purpose solution (MPS), then re-inserted the following morning. Lenses were replaced with new lenses monthly. At each follow-up visit, investigators completed a slit lamp evaluation, and subjects rated lenses based upon a predefined set of performance criteria. RESULTS: The samfilcon A lens performed comparably to the balafilcon A lens in terms of most graded and ungraded slit lamp findings, differing significantly only for corneal staining Grade 2 or greater, which favored samfilcon A, and anterior segment abnormalities, which favored balafilcon A. Subjects rated both lenses highly when queried about various lens-wearing characteristics. When comparing the number of subjects with findings on either eye on at least one follow-up visit, the two lenses were comparable in many aspects but favored samfilcon A with respect to cleanliness upon removal, overall comfort, comfort at end of day, dryness, vision, vision in low light, vision at end of day, and overall impression (all p < 0.05). CONCLUSION: While subjects rated both highly, samfilcon A lenses worn for 7-day extended wear and replaced on a monthly basis performed comparably to or better than balafilcon A lenses when worn for the same 7-day wear time and replacement cycle.

Satisfaction of astigmatic patients with toric nesofilcon A contact lenses.

PURPOSE: The purpose of this evaluation was to compare the experience of habitual contact lens wearers with that of nonwearers when fitted with a novel toric nesofilcon A contact lens (Biotrue ONEday for Astigmatism lens; Bausch & Lomb Incorporated, Rochester, NY, USA), for wearer comfort, vision, and satisfaction in a real-world setting. MATERIALS AND METHODS: Participating eye care practitioners (ECPs) prescribed toric nesofilcon A lenses to their astigmatic patients as part of their routine clinical practices. Accordingly, 1,253 patients successfully completed the evaluation; of these, 51% wore contact lenses habitually, 41% wore eyeglasses, and 8% had no prior vision correction. All wore the lenses for at least 4 days, and 74% wore them for an average of 9 hours or more per day. After at least 4 days of wear, each patient completed an online survey to evaluate his or her level of satisfaction regarding comfort and vision. As this postmarket evaluation was observational, data were analyzed to determine whether more patients than not agreed with individual statements regarding lens performance, and whether there was any difference in response between habitual contact lens wearers and nonwearers. RESULTS: As a measure of general satisfaction, 96% of patients indicated that their overall opinion of the toric nesofilcon A lens was good to excellent. Further, more patients than not agreed that the lens performed well with regard to all aspects of vision and comfort queried (P<0.001). There was no difference in response between habitual contact lens wearers and nonwearers. CONCLUSION: All astigmatic patients with spherical contact lenses, other toric lenses, or eyeglasses, as well as those who had no prior correction, who had converted to the toric nesofilcon A lens expressed a high level of satisfaction with vision and comfort. ECPs should expect high success rates when converting astigmatic patients to the novel toric nesofilcon A lens.

Evaluation of binocular function among pre- and early-presbyopes with asthenopia.

PURPOSE: Individuals approaching presbyopia may exhibit ocular symptoms as they contend with visual demands of near work, coupled with natural age-related changes in accommodation. Therefore, accommodation and vergence of 30- to 40-year-old, myopic, soft contact lens wearing subjects with symptoms of asthenopia and no history of using multifocal lenses were evaluated. PATIENTS AND METHODS: In this prospective, observational study, 253 subjects with asthenopia were evaluated by 25 qualified practitioners, each at a different clinical site. Subjects were 30-40 years in age, had symptoms of soreness, eyestrain, tired eyes, or headaches with near work, regularly performed 2-3 consecutive hours of near work, and were undiagnosed with presbyopia. Amplitude of accommodation (AC) and near point convergence (NPC) were measured with a Royal Air Force binocular gauge. Triplicate push up and push down AC and NPC measures were recorded, and average AC values were compared to those calculated using the Hofstetter formula (HF). RESULTS: The average AC push up/push down value was significantly better than the HF prediction for this age range (8.04±3.09 vs 6.23±0.80 D), although 22.5% of subjects had mean AC below their HF value (5.36±0.99 D). The average NPC push up/push down value was 12.0±4.69 cm. The mean binocular AC value using the push up measure was significantly better than the push down measure (8.5±3.4 vs 7.6±3.0 D). The mean NPC value using the push up measure was significantly worse than the push down measure (13.0±5.0 vs 11.0±4.7 cm). The most frequent primary diagnosis was ill-sustained accommodation (54%), followed by accommodative insufficiency (18%), and accommodative infacility (12%). CONCLUSION: Based upon a standardized assessment of accommodation and vergence, ill-sustained accommodation was the most frequent diagnosis among this population.

Biocidal efficacy of multipurpose solutions against Gram-negative organisms associated with corneal infiltrative events.

BACKGROUND: Because corneal infiltrative events (CIEs) may result from bacterial components on contact lenses, which can come from contaminated lens cases, we evaluated the biocidal efficacy of five multipurpose solutions against Gram-negative commonly isolated and CIE-associated organisms. METHODS: Of the multipurpose solutions tested, one contained polyhexamethylene biguanide (PHMB)/polyquaternium-1 (PQ-1; Bausch & Lomb Incorporated: Biotrue), one contained alexidine dihydrochloride (alexidine)/PQ-1 (AMO: RevitaLens OcuTec) and three contained PQ-1/myristamidopropyl dimethylamine (MAPD; Alcon: Opti-Free PureMoist, PQ-1/MAPD-1; Opti-Free RepleniSH, PQ-1/MAPD-2; Opti-Free Express, PQ-1/MAPD-3). Challenge organisms were CIE-associated Achromobacter xylosoxidans, Delftia acidovorans and Stenotrophomonas maltophilia at manufacturer-recommended durations (stand-alone), in lens cases without lenses (up to seven days) and in lens cases with etafilcon A lenses (up to 30 days). RESULTS: In stand-alone testing against CIE-associated organisms, PHMB/PQ-1 and alexidine/PQ-1 were significantly superior versus MAPD-based multipurpose solutions against A. xylosoxidans (all p ≤ 0.01), D. acidovorans (all p ≤ 0.001) and S. maltophilia (all p ≤ 0.05). In lens cases, PHMB/PQ-1 and alexidine/PQ-1 achieved greater than 3-log reductions against all challenge organisms at all times evaluated. PQ-1/MAPD-1 achieved a greater than 3-log reduction against D. acidovorans at 24 hours; PQ-1/MAPD-1 and PQ-1/MAPD-3 achieved greater than 3-log reductions at seven days against all organisms. In lens cases with lenses, PHMB/PQ-1 and alexidine/PQ-1 achieved greater than 3-log reductions against all organisms at all times. PQ-1/MAPD-1 and PQ-1/MAPD-3 achieved greater than 3-log reductions at seven or more days against all organisms. PQ-1/MAPD-2 did not achieve a greater than 3-log reduction at any time; some regrowth was observed. CONCLUSIONS: PHMB- and alexidine-based multipurpose solutions demonstrated significantly greater biocidal activity compared with PQ-1/MAPD-based agents against Gram-negative organisms commonly isolated and CIE-associated pathogens.

Increased concentration of hyaluronan in tears after soaking contact lenses in Biotrue multipurpose solution.

PURPOSE: This study was conducted to determine 1) the concentration of hyaluronan (HA) in the tear films of contact lens (CL) wearers versus non-CL wearers and 2) whether HA sorbed from Biotrue, an HA-containing multipurpose solution (MPS), onto senofilcon A lenses affects the concentration of HA in tears after 2 hours of wear. PATIENTS AND METHODS: Tears of habitual CL wearers and non-CL wearers were collected on Schirmer strips at baseline and after 2 hours of wear of senofilcon A CLs that had first been either rinsed with Sensitive Eyes Saline or soaked in Biotrue MPS for 14 hours. HA concentrations were measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for sample volumes. RESULTS: No difference in baseline concentrations of HA in tears was found between CL wearers and non-CL wearers (P=0.07), nor between males and females (P=0.06). However, age was significantly negatively associated with HA concentration (P<0.01), and mostly, CL wear contributed to a significant association (P<0.01). Among saline-rinsed CL wearers, no change in HA concentration in tears was observed after 2 hours of wear (P=0.38). By contrast, a significant increase in HA concentration was observed in the tears from eyes that had worn CLs soaked in Biotrue MPS when compared to baseline (P=0.01) or to saline-rinsed control (P=0.03). CONCLUSION: 1) In this study population, no difference in baseline concentration of HA was observed between CL wearers and non-CL wearers, and 2) after 2 hours of wear of senofilcon A lenses that were soaked in Biotrue MPS, HA concentrations in the tear films of CL wearers increased.

Clinical performance of KeraSoft(®) IC in irregular corneas.

PURPOSE: This study evaluated the clinical performance of KeraSoft(®) IC (KIC) soft contact lenses in subjects with irregular corneas. PATIENTS AND METHODS: This was a 12-month, prospective, open-label, observational study, which enrolled 43 subjects who were 18 years of age or older with irregular corneas. Subjects were fit according to the KIC Fitting Manual (kerasoftic.com). After achieving best fit according to the fitting manual, lenses were assessed for comfort, vision, centration, rotation, and movement. Subjects were instructed to wear their lenses between 8 and 16 hours each day. Assessments at the exit visit included logMAR visual acuity with high and low contrast, spherocylindrical overrefraction, slit-lamp findings, adverse events, and subjective outcomes. RESULTS: The average base curve was 8.17±0.32 mm (n=70 eyes), and the average diameter dispensed was 14.53±0.12 mm (n=70 eyes). From the baseline to 12 months, there was statistically significant improvement in logMAR visual acuity with high contrast (P=0.038), but no significant difference in low-contrast visual acuity was observed (P>0.05). Slit-lamp findings were ≤ grade 1 for the majority of subjects (89%). Two nonserious adverse events were reported for two of the 84 enrolled eyes (two subjects). At 12 months, subjects reported improvements from habitual baseline for comfort and vision, both upon insertion and just before removal of lenses. CONCLUSION: Clinical outcomes at 12 months showed good visual, safety, and subjective outcomes for subjects with corneal irregularities who wore KeraSoft(®) IC soft contact lenses.

Acanthamoeba encystment: multifactorial effects of buffers, biocides, and demulcents present in contact lens care solutions.

PURPOSE: To determine whether agents which are purportedly capable of inducing encystment of Acanthamoeba can recapitulate the signal when tested in differing formulations. METHODS: In accordance with the International Standard ISO 19045, Acanthamoeba castellanii ATCC 50370 trophozoites were cultured in antibiotic-free axenic medium, treated with test solutions, and encystment rates plus viability were measured via bright field and fluorescent microscopy. Test solutions included phosphate-buffered saline (PBS), borate-buffered saline, biguanide- and hydrogen peroxide (H2O2)-based biocides, propylene glycol (PG) and povidone (POV) ophthalmic demulcents, and one-step H2O2-based contact lens disinfection systems. RESULTS: Only PBS solutions with 0.25 ppm polyaminopropyl biguanide (PAPB) and increasing concentrations of PG and POV stimulated A. castellanii encystment in a dose-dependent manner, whereas PBS solutions containing 3% H2O2 and increasing concentrations of PG and POV did not stimulate encystment. Borate-buffered saline and PBS/citrate solutions containing PG also did not stimulate encystment. In addition, no encystment was observed after 24 hours, 7 days, or 14 days of exposures of trophozoites to one-step H2O2 contact lens disinfection products or related solutions. CONCLUSION: The lack of any encystment observed when trophozoites were treated with existing or new one-step H2O2 contact lens care products, as well as when trophozoites were exposed to various related test solutions, confirms that Acanthamoeba encystment is a complex process which depends upon simultaneous contributions of multiple factors including buffers, biocides, and demulcents.

Patient satisfaction with a novel one-step hydrogen peroxide solution.

PURPOSE: We aimed to evaluate the product performance of a novel one-step hydrogen peroxide cleaning and disinfecting solution, PeroxiClear ("Test" solution), when used by habitual Clear Care users to bilaterally clean and disinfect their soft contact lenses, for approximately 2 weeks. METHODS: This was a 2-week, open-label, bilateral eye study designed to include subjects ranging in age from 18 to 55 years, inclusive. All subjects were habitual users of the Clear Care peroxide regimen for cleaning, disinfecting, and storage of their soft contact lenses, for at least 6 months prior to enrolling in the study. Subjects were examined at two study visits: a screening/dispensing visit and a 2-week follow-up visit. The primary end point, patient preference for the Test solution, was evaluated with an online survey administered after 7 days of using the Test cleaning and disinfecting solution. Respondents could answer questions with neutral or nonneutral responses (better or worse). Statistical analyses were conducted to compare differences for nonneutral responses. RESULTS: Of the 299 eligible subjects enrolled, 297 completed the study, conducted at 21 sites by 21 investigators in the United States. A significantly higher proportion of nonneutral respondents reported the Test solution was better overall (85.9%) than their habitual contact lens solution (14.1%) (P<0.001). The proportion of subjects who preferred the Test solution over their habitual solution was significantly higher for each of the preference questions regarding comfort (85.4% vs 14.6%), moistness (90.0% vs 10.0%), cleanness (91.6% vs 8.4%), and clarity of vision (85.8% vs 14.2%). CONCLUSION: After 7 days of using the Test cleaning and disinfecting solution, survey results indicated high levels of patient satisfaction and preference over the habitual solution, particularly in the areas of comfort, moisture, and cleanness.

Reducing dropout of contact lens wear with Biotrue multipurpose solution.

PURPOSE: To evaluate whether the use of Biotrue multipurpose solution (MPS) could significantly reduce the likelihood with which patients drop out of using daily wear contact lenses (CLs) amongst 18-44-year-old frequent replacement CL wearers. METHODS: Daily wear CL subjects habitually using MPSs (other than Biotrue MPS) who reported an intent to imminently drop out of CL wear because of comfort and dryness complaints were recruited to participate in this investigation. Subjects were switched to Biotrue MPS and continued to use habitual CL types with the new MPS for 2 weeks. Subjects completed an online satisfaction questionnaire at baseline and after 2 weeks to assess the change in symptoms and the intent to drop out of CL wear. Six months after completion of the initial study, a follow-up survey was administered to a subset of the initial participants. RESULTS: A total of 153 daily wear (silicone hydrogel and hydrogel) subjects completed this 2-week study with Biotrue MPS. When measuring those with the highest propensity to drop out of lens wear (n=93) after switching to Biotrue MPS, 90% of subjects significantly reduced their likelihood of dropping out of CL wear (P<0.0001). Online interviews were conducted with 73 of the study participants 6 months after completion of the initial study. A total of 93% of participants responded that they were still wearing CLs at least once per week. Of the 7% of respondents who were not currently wearing lenses 6 months after the initial study, two had dropped out of lens wear completely, and three still wore lenses less than once per week. CONCLUSION: Patients intending to drop out of CL wear due to discomfort and dryness significantly reduced their propensity of discontinuing lens wear following use of Biotrue MPS. Six months after completion of the study, 93% of patients were still wearing CLs at least once per week.

Comparative studies of hyaluronan in marketed ophthalmic products.

PURPOSE: Research has indicated that there is a correlation between the molecular weight of hyaluronan or hyaluronic acid (HA) and its biocompatibility/biological functions with high molecular weight HA showing many biological benefits. The purpose of this research was to characterize and compare the molecular weights, molecular weight distributions, and concentrations of HA present in a series of commercially available HA-containing ophthalmic products. METHODS: On-line size-exclusion chromatography with triple detection (SEC-TD) was used to determine the molecular weights and concentration of HA in commercially available products, including marketed contact lens multipurpose solutions and contact lens packaging solutions. Eleven commercially available HA-containing ophthalmic products were characterized by SEC-TD. RESULTS: The weight-average molecular weights of the products tested ranged from 155,000 Daltons (Da) to 1,400,000 Da, the number-average molecular weight of the products ranged from 99,000 to 927,000 Da, and the concentration of HA ranged from 0.003 to 0.15%. CONCLUSIONS: A wide range of HA molecular weights and concentrations were found in the 11 ophthalmic products characterized in the present study. This study is the first reported to characterize HA molecular weights and concentrations in various marketed HA-containing ophthalmic products. Future investigation of the effect of low molecular weight HA on eye is required.

A meta-analysis of studies on cosmetically tinted soft contact lenses.

BACKGROUND: Concerns regarding the safety of cosmetically tinted contact lenses have been reported in the literature. The purpose of this paper is to evaluate the safety of cosmetically tinted contact lenses in a large number of patients across six clinical trials that varied from 1 week to 3 months in duration. METHODS: LENSES TESTED INCLUDED: Naturelle limbal ring daily disposable, Lacelle limbal ring daily disposable, Lacelle colored cosmetic daily disposable, Lacelle limbal ring planned replacement at 2 weeks, and Alamode traditional/annual colored cosmetic lens. The primary safety outcome was slit-lamp examination, including epithelial edema, epithelial microcysts, corneal staining, bulbar injection, limbal injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. High contrast logMAR visual acuity with lenses, and lens wearing time, movement, and centration, are also presented. RESULTS: A total of 871 subjects (1,742 eyes) and 23 clinical investigators participated in the six studies, with an average completion rate of 96.4% across all studies. The mean age of the patients was 26.8 ± 6.6 years, and 86.7% of participants were female. The total number of slit-lamp examinations across the six studies was 2,456 visits by eye (1,228 visits by patient). There were no slit-lamp signs > grade 2 for any finding, with the exception of corneal staining in one study. In this study, grade 3 corneal staining was noted in one eye (0.1%) at follow-up visit 1 and four (0.6%) of all eligible dispensed eyes at follow-up visit 2, with no eyes requiring medical treatment. No adverse events were reported during any of the trials. CONCLUSION: The cosmetically tinted lenses evaluated in this meta-analysis appear to be safe when properly prescribed by an eye care professional and used in a compliant manner.

Meta-analysis of the ocular biocompatibility of a new multipurpose lens care system.

BACKGROUND: The purpose of this paper is to evaluate the biocompatibility of a novel multipurpose solution (MPS) with a dual disinfectant system containing polyaminopropyl biguanide and polyquaternium-1 (Biotrue®) by analysis of biomicroscopy signs and adverse events in six large clinical trials. METHODS: Data from six consecutive, prospective clinical trials conducted from February 2008 to March 2010 were combined for meta-analysis. Subjects used the new MPS daily for periods of 2 weeks to 6 months. Slit-lamp signs were graded at each follow-up visit using an ordinal scale (0, one; 1, trace; 2, mild; 3, moderate; 4, severe). Analysis for biocompatibility included tracking of greater than grade 2 slit-lamp findings and number of adverse events. RESULTS: A total of 1,567 subjects (3,134 eyes) and 81 clinical investigators participated in the six studies, with 1,499 subjects completing the studies. Based on subject days in the studies, there were 72,904 exposures to the MPS and 7,212 biomicroscopy examinations. The completion rate for the studies was 96.3%. Per observation incidence of any finding greater than grade 2 at the follow-up visits were: corneal staining 0.08%, limbal injection 0.04%, bulbar injection 0.04%, tarsal conjunctiva abnormality 0.09%, and neovascularization 0.01%. There were no other slit-lamp signs greater than grade 2 and no statistically significant difference between hydrogels and silicone hydrogels for any finding. There were no reports of adverse events during the trials. CONCLUSION: Analysis of over 72,000 daily exposures and 7,212 eye examinations showed that the novel MPS exhibited excellent biocompatibility in subjects using daily wear hydrogel or silicone hydrogel lenses.

A review of hyaluronan and its ophthalmic applications.

Hyaluronan (HA) is a naturally occurring, biocompatible polysaccharide with unique viscoelastic and hygroscopic properties. Its role as a natural lubricant and its excellent water-retaining properties make it well-suited for use in ophthalmic products. Many reports have been written describing the various uses of HA. The purpose of this report is to review the uses of HA in the anterior segment of the eye, more specifically, its use in the treatment of dry eye syndrome, and in contact lenses and contact lens care systems.

A comparison of spectacle and contact lens wearing times in the ACHIEVE study.

PURPOSE: The aim was to compare vision correction wearing time between myopic children and teenagers in a clinical trial of contact lenses and spectacles. METHODS: Parents of subjects in the Adolescent and Child Health Initiative for Vision Empowerment (ACHIEVE) study provided wearing times for spectacle and contact lens wear. Hours wearing primary correction and total correction were compared between the two treatment groups. Other factors hypothesised to be associated with wearing time were analysed. RESULTS: The average wearing time of the primary correction differed significantly with the wearing time for the spectacles group being 91.5 hours per week compared to 80.3 hours per week for the contact lens wearers (p < 0.0001). Total correction time was slightly higher for the contact lens wearers, 97.5 hours per week, after accounting for time wearing spectacles. Higher refractive error was strongly related to longer wearing times (p < 0.0002). Age and treatment group were associated with wearing time (p = 0.005). Young contact lens wearers wore their lenses less than young spectacle wearers and older contact lens wearers. Low scores on an appearance quality-of-life scale were associated with longer wearing time in spectacle wearers compared to the low- and high-scoring contact lens wearers. Gender, spectacle satisfaction and activities were not related to wearing time. CONCLUSIONS: While contact lens wearers, on average, wear their contact lenses less than spectacle wearers, they spend roughly the same amount of time wearing a refractive correction. Higher refractive error resulted in longer wearing times for both spectacle and contact lens wearers. Younger contact lens wearers wore their contact lenses for shorter periods than the spectacle wearers, but still wore them, on average, 74.4 hours per week (about 10 hours per day), suggesting that contact lenses are a viable alternative mode of correction for children.

Vision specific quality of life of pediatric contact lens wearers.

PURPOSE: Several studies have shown that children are capable of wearing and caring for contact lenses, but it is not known whether the benefits outweigh the risks associated with contact lens wear. The purpose of this article is to compare the vision-related quality of life benefits of children randomized to wear spectacles or contact lenses for 3 years using the Pediatric Refractive Error Profile. METHODS: The Pediatric Refractive Error Profile was administered to 484 children who wore glasses at baseline. The children were then randomly assigned to wear contact lenses (n = 247) or spectacles (n = 237) for 3 years. The survey was administered at the baseline examination, at 1 month, and every 6 months for 3 years. RESULTS: During 3 years, the overall quality of life improved 14.2 +/- 18.1 units for contact lens wearers and 2.1 +/- 14.6 units for spectacle wearers (p < 0.001). In all scales except the visual performance scales (Distance Vision, Near Vision, and Overall Vision), the quality of life improved more for older subjects than younger subjects. The three scales with the largest improvement in quality of life for contact lens wearers were Activities, Appearance, and Satisfaction with Correction. CONCLUSIONS: Myopic children younger than 12 years of age report better vision-related quality of life when they are fit with contact lenses than when they wear glasses. Older children, children who participate in recreational activities, children who are motivated to wear contact lenses, and children who do not like their appearance in glasses will benefit most.

Gas permeable and soft contact lens wear in children.

PURPOSE: To compare children's reports of comfort, vision, and contact lens-related issues in gas permeable (GP) and soft (SCL) contact lens wearers. METHODS: Subjects were 116 8- to 11-year old children in the Contact Lenses and Myopia Progression Study. Aspects of contact lens wear were compared for children remaining in their original treatment group (either GPs or SCLs) for 3 years. Questionnaires were completed at every visit, as was visual acuity. Comparisons were made between the two groups using logistic regression or mixed linear models analyses as appropriate to examine the contact lens wearing experience. Additionally, children crossing over from GP wear to SCLs were compared with children remaining in GP lenses to determine the potential factors related to GP dissatisfaction. RESULTS: Seventy percent of GP wearers and 93% of SCL wearers wore their assigned lenses every visit. GP wearers wore their lenses significantly fewer hours per week than the SCL wearers (76.2 h/week vs. 86.8 h/week, respectively, p = 0.003). GP wearers had statistically significantly better visual acuity though the difference was not clinically meaningful (p < 0.001). Comfort was poorer among the GP wearers using the Ocular Pain subscale (p < 0.001) but did not differ using a subjective question about comfort. Symptoms were more frequent in GP wearers than SCL wearers (p = 0.002) and were related to reports of discomfort. Significant factors relating to crossing over from GPs to SCLs were lower wearing time with GPs and itching. CONCLUSIONS: Children are able to successfully wear GP and soft contact lenses. Long-term adaptation occurred more frequently to SCLs than to GPs. The amount of time GP lens wearers are able to comfortably wear their contact lenses and the amount of itching may help determine whether they will remain in that modality.

Purchase of contact lenses and contact-lenses-related symptoms following the Contact Lenses in Pediatrics (CLIP) Study.

BACKGROUND: The rate and reasons for discontinuation of contact lens wear by young patients are not well known. The Contact Lenses in Pediatrics (CLIP) Study surveyed participants 3 months after the final study visit to determine the percentage of participants who continued to wear contact lenses after study conclusion. The factors associated with continued contact lens wear and differences in behaviors between the children and teens were also determined to provide insights to practitioners who provide refractive correction for patients in those age groups. METHODS: Three months after the CLIP Study completion, participants and parents returned mailed surveys that assessed post-study lens purchase and symptoms related to contact lens wear if contact lenses wear had been continued. Responses were compared between the children and teens using chi(2) or Fisher's exact test. RESULTS: Almost 92% of the surveys were returned. Eighty percent of teens' parents reported purchasing lenses after the study, vs. 63% of the children's parents (p=0.02). Symptoms reported at the last study visit were not significantly associated with future purchase, though there was a trend towards more light sensitivity in those who did not purchase more contact lenses (23.1% vs. 11.8%). Satisfaction with contact lenses was high among both those purchasing additional contact lenses and those who did not. Both children and teens reported similar frequencies of symptoms such as burning, itching or tearing eyes 3 months following study completion. Teens reported having contact-lens-related dry eyes more frequently than children. CONCLUSIONS: A large proportion of children and an even higher proportion of teens continued wearing their lenses 3 months after completing the CLIP Study. Children and teens reported similar contact lens comfort and low frequencies of most symptoms, though teens experienced more dry-eye symptoms. Overall, reports of symptoms in this sample were lower than had been reported in adult populations by other investigators.

A comparison of multipurpose and conventional 2-step rigid gas-permeable solutions with Paragon corneal refractive therapy lenses.

PURPOSE: This investigation compared 2 commonly used care systems, Boston Advance(R) care system and Boston Simplus (Bausch & Lomb, Rochester, New York) multipurpose solution, and the effects of these solutions on unaided daytime vision, care, and handling and comfort with Paragon corneal refractive therapy (CRT)(R) (Paragon Vision Sciences, Mesa, Arizona) lenses. METHODS: Eighteen subjects wearing CRT lenses were recruited. Three evaluations were conducted over 2 months. Subjects were randomly assigned a solution and returned for a follow-up visit after 1 month. At the conclusion of the 1-month visit, each patient was reassigned the other solution for the second month. The final visit included an additional questionnaire regarding which solution was deemed the best and worst for unaided daytime vision, comfort, care, and handling. RESULTS: From the responses of the 18 patients, a trend is evident that patients favor Boston Simplus over Boston Advance for comfort, unaided daytime vision, and care and handling. However, the sample size is small in this study; therefore, most of the differences are not significant at the 0.05 level except the preference for care and handling (P = 0.03). CONCLUSIONS: Patients preferred Boston Simplus to Boston Advance with corneal reshaping lens wear when evaluated for comfort, unaided daytime vision, and care and handling. The preference of Boston Simplus to Boston Advance for care and handling is very strong and statistically significant, whereas other such advantages of Boston Simplus were not found to be statistically significant in this study. Further confirmation of these results as well as a better understanding of other visual and ocular interactions of Boston Simplus versus conventional solutions, will require using a larger sample in further studies.