Safe and Effective Management of Dry Eye Symptoms with Hydroxypropyl Guar and Hyaluronic Acid Dual-Polymer Lubricating Eye Drops: A Review of Preclinical and Clinical Studies.

Dry eye disease (DED) is a chronic ocular surface disorder often characterized by decreased tear production and rapid tear evaporation that affect tear film stability and homeostasis. The common symptoms of DED include ocular discomfort, visual disturbances, dryness, and itching. Artificial tears are the mainstay of DED management and supplement one or more layers of the tear film. Artificial tear drops are available as a combination of viscosity-enhancing agents (demulcents/lubricants), humectants, and buffers either with or without preservatives. Artificial tears, as a combination of components (polymers/demulcents/viscosity-enhancing agents), can provide synergistic action compared with a single component for the management of multifactorial signs and symptoms of DED. This review describes the formulation components, physicochemical properties, mechanism of action, and summary of preclinical and clinical evidence on the hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricant eye drops (SYSTANE™ HYDRATION). The dual-polymer eye drops consist of dual demulcents (propylene glycol and polyethylene glycol 400) and the polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA). When instilled on the ocular surface, HPG forms a cross-linked gel matrix with borate ions that prolongs the retention of demulcents, thus providing long-lasting lubrication and ocular surface protection. Additionally, HA stabilizes the tear film, increases corneal wettability, and reduces friction during blinks due to its hygroscopic and viscoelastic properties. Preclinical evidence demonstrates that HPG HA dual-polymer lubricant eye drops provide protection against desiccation by cell hydration and surface retention, cell barrier protection, prolonged lubrication, and promotion of corneal re-epithelialization. Clinical scientific evidence demonstrates that HPG HA dual-polymer lubricant eye drops are safe and effective in the management of DED. Specifically, they reduce the signs and symptoms of DED, reduce dry eye symptoms post-cataract surgery, and improve tear film quality in healthy eyes.

Relieving the symptoms of dry eye disease: update on lubricating eye drops containing hydroxypropyl-guar.

Hydroxypropyl-guar (HPG) is a thickening agent first added to lubricating eye drops in 2003. This agent, which enhances viscosity, has been used in the SYSTANE® family of lubricant eye drops (Alcon Laboratories, Inc., Fort Worth, TX, USA). HPG forms a partially linked gel with borate to prolong the retention of demulcents, such as polyethylene glycol and propylene glycol, on the eye. This helps to protect the ocular surface, thereby reducing the symptoms of dry eye disease (DED). The definition of DED has evolved with advances in research, leading to changes in HPG-containing eye care solutions. This article reviews current knowledge on the use of HPG-containing lubricating eye drops in the management of DED.

Hydrogen Peroxide Disinfecting Solution for Gas Permeable Contact Lenses: A Review of the Antimicrobial Efficacy, Compatibility, and Safety Performance of a One-Step Lens Care System.

CLEAR CARE PLUS (CCP), also known as AOSEPT PLUS with HydraGlyde, is approved for use with gas permeable (GP) lenses, and the indication is supported by the scientific evidence that is reviewed in this article. Antimicrobial efficacy testing of CCP both as a stand-alone disinfectant and as part of a regimen shows that CCP exceeds the ISO 14729 criteria against bacteria, yeast, and mold. In real-world conditions, it is effective against clinically relevant bacterial strains isolated from adverse events and against the two forms, trophozoites and cysts, of resilient Acanthamoeba species. Compatibility tests of CCP with two types of GP lenses indicate that the physical and/or optical parameters of lenses are unaffected through 30 cycles of simulated use with CCP, and a clinical trial shows substantial equivalence of clinical performance with a commonly used GP multipurpose solution. These results indicate that CCP is well suited for cleaning and disinfection of GP contact lenses.

The influence of lens care systems on eyelid tissue changes during silicone hydrogel contact lens wear.

PURPOSE: To compare the effects of a hydrogen peroxide (H2O2)-based lens care solution and a polyhexamethylene biguanide (PHMB) multi-purpose solution on the eyelids when used with silicone hydrogel (SiHy) contact lenses. METHODS: A total of 74 symptomatic wearers of ACUVUE® OASYS® (senofilcon A; n = 39) or PureVision® (balafilcon A; n = 35) contact lenses were randomised 1:1 to either CLEAR CARE® Cleaning & Disinfecting Solution or renu® fresh™ multi-purpose solution (n = 37 each). Assessments of hyperaemia, papillae and lid margin staining of eyelid tissue were evaluated subjectively by a masked investigator at enrolment (with the subjects' habitual SiHy contact lenses and PHMB-preserved care systems), at dispensing visit (when no lenses were worn) and at 3-months' follow-up. RESULTS: There were no differences in eyelid assessments between the two lens care groups at dispensing visit (p = 0.086 to 0.947). After 3 months, the papillae response was significantly less marked with H2O2-based solution than with PHMB-based solution (p = 0.017). Lid hyperaemia (p < 0.001) and papillae (p = 0.002) were also significantly reduced. Although lid hyperaemia was also reduced with PHMB-based solution (p < 0.001), there was no concurrent decrease in papillae response (p = 0.051). No improvements were found in eyelid margin staining either over time or between the two lens care groups. CONCLUSION: In symptomatic contact lens wearers, a H2O2-based lens care solution used with senofilcon A and balafilcon A lenses was better tolerated by eyelid tissues than was a PHMB-based solution and led to a decrease in clinical markers of eyelid inflammation.

Effect of lens care system on silicone hydrogel contact lens wettability.

PURPOSE: The purpose was to compare the effect of the repeated usage of two care systems (one hydrogen peroxide cleaning and disinfecting system and one polyaminopropyl biguanide (PHMB) containing multi-purpose system) with silicone hydrogel contact lenses worn for three months on a daily wear modality. A specific aspect of interest was of the effect of the care systems on contact lens wettability. METHODS: Seventy-four symptomatic contact lens wearers, habitually wearing either ACUVUE(®) OASYS(®) (n=37) or PureVision™ (n=37), constituted the study population. The study was a two-arm prospective, investigator-masked, bilateral study of three-month duration to evaluate the effects of CLEAR CARE(®) compared with renu(®) fresh™. The subjects were randomized to one of the two lens care systems. Contact lens wettability and surface cleanliness were assessed with the Tearscope and reported in terms of pre-lens non-invasive break-up time (PL-NIBUT) and visible deposits. Baseline assessments at enrollment were with the subjects' own contact lenses worn for at least 6h when using their habitual PHMB-preserved care system and at the dispensing visit with new contact lenses. At the follow-up visits, the contact lenses were worn for at least 6h, and were at least 11 days old for ACUVUE(®) OASYS(®) and 25 days old for PureVision™. RESULTS: The results obtained showed that: (i) with CLEAR CARE(®), a significant improvement in contact lens wettability was recorded compared with the habitual care system at the three-month follow-up visit (mean median PL-NIBUT 5.8 vs. 4.0 s, p<0.001). Further, with this same lens care system a significant increase in wettability was observed at the three-month follow-up visit compared with dispensing (mean median PL-NIBUT 5.8 vs. 4.5s, p=0.022). (ii) Whereas no difference in contact lens wettability was observed at dispensing between the two lens care groups (mean PL-NIBUT: 4.5 vs. 4.2s, p=0.518), a significantly more stable pre-lens tear film was observed with CLEAR CARE(®) than with renu(®) fresh™ at both the two-month (mean PL-NIBUT: 4.6 vs. 3.7s, p=0.005) and three-month (mean PL-NIBUT: 5.8 vs. 4.2 s, p=0.028) visits. iii. With renu(®) fresh™, no significant differences were observed at the end of three months of use compared with either the habitual care system or the new contact lens solution (mean PL-NIBUT: 3M 4.2 vs. Disp 4.2 s (p=0.420) vs. enrolment habitual care solution 5.1s (p=0.734)). iv. With CLEAR CARE(®) significant increases in the incidence of surfaces free of both mucus (3 month 95%. vs. habitual solution 82% enrolment; p=0.005) and lipid (3 month 87% vs. habitual solution 72% enrolment; p=0.009) were observed. CONCLUSION: Significantly better contact lens wettability and surface cleanliness were achieved for ACUVUE(®) OASYS(®) and PureVision™ with CLEAR CARE(®) than with renu(®) fresh™ at the end of three months of use.

Contact lens lipid spoliation of hydrogel and silicone hydrogel lenses.

PURPOSE: The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVision (balafilcon A) and hydrogel Acuvue 2 (etafilcon A) contact lenses worn for 10 hours single use (DD) and 7 days of extended wear (EW). METHODS: Two similar study populations (DD, n = 55; EW, n = 53), were enrolled at four study sites. In each population, a bilateral, randomized, crossover (lens material), subject-masked experimental design was followed. Worn contact lenses were analyzed for lipid uptake using high-performance liquid chromatography by two laboratories: Alcon Laboratories (right lens total uptake) and OTG Research & Consultancy (left lens total uptake and individual lipid classes). RESULTS: Lipid uptake was different for the two materials: total lipid (p < 0.007), cholesterol esters (p < 0.001), cholesterol (p < 0.001 EW only), and triglycerides/phospholipids (p < 0.001) were higher for balafilcon A, whereas fatty acid (p < 0.0025 EW only) was higher for etafilcon A. The ratio of the extracted lipids was also different: higher percentages of triglycerides/phospholipids (p < 0.001) and cholesterol (p < 0.001 EW only) for balafilcon A and higher percentages of fatty acids/di- and monoglycerides (p < 0.014) for etafilcon A. CONCLUSIONS: Total lipid uptake was highly material dependent. Both laboratories measured a greater uptake of lipids by the silicone hydrogel than the hydrogel material, a difference that was evident after only 10 hours of DD. Total lipid uptake was greater after 7 days of EW compared with 10 hours of DD. Of interest for contact lens spoliation and its avoidance was the differential lipid uptake profile, indicating material selectivity. Whereas greater differentiation between materials was possible after 7 days of EW for each material, the lipid uptake profile was similar for DD and EW, indicating a greater material effect than a wear modality effect.

Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis.

OBJECTIVES: The principal objective of the study was to measure the conjunctival staining produced in the circumlimbal region by silicone hydrogel contact lenses with different edge designs. The secondary objective was to investigate the association between circumlimbal staining and comfort. METHODS: Four silicone hydrogel contact lenses: ACUVUE OASYS (knife edge design), AIR OPTIX, Biofinity (chisel edge rounded edge combination), and PureVision (rounded edge design), and 1 hydrogel contact lens, ACUVUE 2 (knife edge design), were tested. The study was conducted on a cohort population of 27 established soft contact lens wearers, who wore each contact lens type, in a random order, for a period of 10 (±2) days. Circumlimbal staining was measured in a double-masked fashion through image analysis of digital photographs of lissamine green taken under controlled experimental conditions. RESULTS: The results obtained showed that contact lens edge design was the primary factor controlling circumlimbal staining for silicone hydrogel lenses: a rounded edge away from the ocular surface produced the lowest staining (average, 0.19%) and a knife edge in close apposition to the ocular surface produced the highest staining (average, 1.34%). Contact lens material rigidity was also identified to affect circumlimbal staining and an inverse association between circumlimbal staining and contact lens comfort was demonstrated: the rounded edge design produced the lowest comfort (72 of 100) and the knife edge design produced the highest (87 out of 100). CONCLUSION: Soft contact lens wear induces circumlimbal staining, the level of staining being influenced by the contact lens edge design. However, high level of circumlimbal staining is not associated with decreased comfort.

The effect of temperature on soft contact lens modulus and diameter.

PURPOSE: To examine the relative changes in diameter and modulus of soft contact lenses when the temperature is raised from room temperature (RT) to eye temperature (ET). METHODS: Thirteen lens types including 9 silicone hydrogel lenses were measured for diameter and elastic modulus at RT (20 ± 1°C) and ET (34 ± 1°C). Lens diameter measurements were undertaken after equilibration in ISO saline in a temperature-controlled lens analyzer (Optimec, Ltd, Malvern, United Kingdom). Measurements of flexural modulus of elasticity were made using an Instron 3343 tensiometer (Instron, Norwood, MA) with the samples suspended in a temperature-controlled saline bath. RESULTS: All lens types reduced in diameter when raised to ET. The largest mean changes with silicone hydrogel and conventional hydrogel lenses were with Biofinity (Δ0.35 mm) and Acuvue 2 (Δ0.28 mm), respectively. All the silicone hydrogels showed a statistically significant reduction in modulus when raised to ET ranging from Δ0.06 MPa with comfilcon A to Δ0.78 MPa with balafilcon A. All the conventional hydrogels showed relatively small changes (<0.05 MPa) in modulus. Two of the four conventional hydrogels showed a statistically significant change in modulus (etafilcon A and ocufilcon A), but these were small and believed to be clinically insignificant. CONCLUSIONS: This study has highlighted some clinically relevant changes in soft contact lens modulus and diameter when raised from RT to ET. It has also shown the importance of standardizing modulus measurement technique.

Corneal staining and subjective symptoms with multipurpose solutions as a function of time.

PURPOSE: Short-term changes in corneal staining and ocular symptoms were assessed at defined intervals to evaluate combinations of three soft lenses and four multipurpose solutions. METHODS: A series of pilot studies were conducted over 11 months using a double-masked, randomized, crossover design. Asymptomatic, adapted, daily-wear soft lens users wore group II or IV soft hydrophilic or silicone hydrogel lenses for a maximum period each day. Before wear, new lenses were soaked overnight in one of four multipurpose solutions: Alcon OPTI-FREE Express MPDS, Bausch & Lomb ReNu MultiPlus Multipurpose Solution, CIBA Vision SOLO-Care PLUS Multipurpose Solution, or AMO Complete MoisturePLUS. Subjects rated comfort and ocular symptoms. Corneal staining type and area were evaluated at baseline and after lens removal. RESULTS: Significantly increased extent of corneal staining, defined as the proportion of corneal zones showing staining of grade 1 or more severe, was observed at 1 and 2 hours when subjects wore group II lenses soaked in the polyhexamethylene biguanide-based systems. Significantly increased extent of staining was observed at 2 hours when subjects used silicone hydrogel lenses soaked in regimen 4. When subjects used regimen 1 and wore group II lenses, only a minimal staining response was observed at 1 and 2 hours of wear. Significant symptoms were not correlated with extent of staining. CONCLUSIONS: This study design is a promising tool that can discriminate between the performance of different soft lens and multipurpose solution combinations rapidly using small patient samples. With some lens-care product combinations, corneal appearance may vary according to the time of day the patient is examined.

Comparison of ease of swallowing of dietary supplement products for age-related eye disease.

OBJECTIVE: To examine patients' perceptions on the relative importance of the physical characteristics and appearance of dietary supplements, and to evaluate two supplements with the same combination of vitamins and minerals used in the Age-Related Eye Disease Study (AREDS) with respect to ease of swallowing and other features in elderly patients. DESIGN: A single-site, single-visit, crossover design, subject-masked comparison of two dietary supplements (ICaps AREDS Formula--Alcon; Ocuvite PreserVision-Bausch & Lomb). SETTING: Ophthalmology practice. PATIENTS: 50 patients aged 50 years or older. INTERVENTIONS: Patients ranked the importance of eight physical characteristics of a vitamin tablet or capsule (ease of swallowing, size, shape, color, smell, coating, texture, and taste) irrespective of the test products used in the study and then took both test products randomly and were asked to indicate which product they preferred based on the same eight characteristics. MAIN OUTCOME MEASURES: Overall patient preference and preference for swallowing two tablets at once. RESULTS: The highest rated (most important) characteristic in a vitamin supplement was ease of swallowing, with a median score of 9.0 on a 0-10 visual analogue scale. The characteristic of least importance was tablet color, with the lowest median score of 1.0. Statistically significant differences were detected between the products with regard to preferences for ease of swallowing, swallowing two tablets at once, size, and coating (P < or = .0001). Significantly more patients preferred the ICaps AREDS formula to Ocuvite PreserVision with respect to these characteristics and overall preference (P < .001). Age, gender, and previous vitamin use were contributing factors in the rating of physical characteristics and tablet preferences. CONCLUSION: Based on the results of this study, ease of swallowing is the most important characteristic of dietary supplement tablets for elderly patients, followed by taste, size, and smell. Significant differences in preference exist between the study products, which contain similar formulations but have different physical characteristics.