Effect of using a combination of lid wipes, eye drops, and omega-3 supplements on meibomian gland functionality in patients with lipid deficient/evaporative dry eye.

PURPOSE: The aim of this study was to assess the efficacy of using a combination treatment approach consisting of lipid emulsion eye drops, eyelid cleansing wipes, and omega-3 vitamin supplements compared with warm compresses in improving meibomian gland functionality in patients with lipid-deficient/evaporative dry eye disease (LDDE). METHODS: This single-center, open-label, investigator-masked, randomized study enrolled patients aged ≥18 years, clinically diagnosed with LDDE defined as having ≤6 functional meibomian glands [meibomian gland yielding liquid secretion (MGYLS)] and positive for dry eye symptoms at screening. Patients were randomized to receive either the combination treatment (lipid emulsion eye drops, omega-3 supplements, and lid hygiene with eyelid wipes) or to apply warm, wet compresses once daily, 8 minutes per day, for 3 months. Meibomian gland functionality (number of MGYLS; primary outcome) and patient-reported subjective assessments (SPEED and OSDI questionnaires; secondary outcomes) were evaluated. Adverse events (AEs) and visual acuity were assessed as safety endpoints. RESULTS: Mean patient age was 41.7 years (n = 26; n = 13 per group). Mean ± SD number of MGYLS was not statistically significantly different between groups at baseline (combination treatment, 3.5 ± 1.5; warm compresses, 4.2 ± 1.4, P > 0.5), and was significantly greater with combination treatment versus warm compresses after 3 months of treatment (9.3 ± 2.7 vs. 4.7 ± 2.3; P = 0.006). Dry eye symptoms were significantly improved in both groups at all follow-up visits. Two AEs unrelated to treatment were reported; the BCVA was unchanged from baseline in both groups. CONCLUSIONS: The combination treatment regimen resulted in significant improvement in meibomian gland functionality and dry eye symptoms. No safety issues were observed.

Prevalence of lid wiper epitheliopathy in subjects with dry eye signs and symptoms.

PURPOSE: The purpose of this study was to investigate the prevalence of lid wiper epitheliopathy (LWE) in patients diagnosed with dry eye disease (DED). METHODS: Patients were recruited for two groups. Inclusion criteria for the DED group (n = 50) was: a score greater than 10 with the Standard Patient Evaluation of Eye Dryness questionnaire, fluorescein break-up time 5 seconds or less, corneal and conjunctival staining with fluorescein, lissamine green Grade 1 or greater (scale 0-3), and Schirmer test with anesthesia 5 mm or less. For the asymptomatic group (n = 50), inclusion criteria were: no dry eye symptoms, fluorescein break-up time 10 seconds or greater, no corneal or conjunctival staining, and Schirmer test 10 mm or greater. Sequential instillations (n = 2, 5 minutes apart) of a mixture of 2% fluorescein and 1% lissamine green solution were used to stain the lid wipers of all patients. LWE was graded (scale 0-3) using the horizontal lid length and the average sagittal lid widths of the stained wiper. RESULTS: In symptomatic patients, 88% had LWE, of which 22% was Grade 1, 46% Grade 2, and 20% Grade 3. In asymptomatic patients, 16% had LWE, of which 14% was Grade 1, 2% was Grade 2, and 0% Grade 3. The difference in prevalence of lid wiper staining between groups was significant (P < 0.0001). CONCLUSIONS: The prevalence of LWE was six times greater for the DED group and the prevalence of LWE Grade 2 or greater was 16 times greater for the DED group than for the control group. These data further establish LWE as a diagnostic sign of dry eye disease.

An evaluation of the efficacy of fluorescein, rose bengal, lissamine green, and a new dye mixture for ocular surface staining.

PURPOSE: Sodium fluorescein is considered the premier dye for corneal staining and, similarly, rose bengal (RB) for conjunctival staining. A mixture of 1% fluorescein and 1% rose bengal has been reported as advantageous in daily practice. Mixtures of lissamine green with other ocular stains have not been reported. The purposes of this study were to review the clinical staining characteristics of fluorescein, rose bengal, and lissamine green in controlled dose and concentration and determine whether optimal staining of the cornea and bulbar conjunctiva are possible by using dye mixtures. METHODS: Sixteen 10-microL solutions of fluorescein, rose bengal, lissamine green, and their mixtures were evaluated. Fourteen subjects with a diagnosis of dry eye were tested for staining with various combinations of the dyes. Examination of staining was made by using standard clinical practices. RESULTS: A mixture of 2% fluorescein and 1% rose bengal was the most efficacious staining mixture for the cornea and conjunctiva, but moderate to marked discomfort was reported. The mixture of 2% fluorescein and 1% lissamine green did not result in discomfort and provided optimal corneal and conjunctival staining with only slightly less efficacy than 2% fluorescein and 1% rose bengal; 2% and 3% lissamine green produced burning and discomfort. The fluorescent characteristics of fluorescein were not significantly altered by the addition of 1% lissamine green. The preferred mixture for simultaneous and efficacious staining of the cornea and conjunctiva without an adverse sensation was 2% fluorescein and 1% lissamine green. CONCLUSIONS: A mixture of 2% fluorescein and 1% lissamine green offers excellent simultaneous corneal and bulbar conjunctival staining and could replace the use of individual dyes for ocular staining and contact lens practice.

The effect of two novel lubricant eye drops on tear film lipid layer thickness in subjects with dry eye symptoms.

PURPOSE: Because the lipid layer of the tear film is recognized as a critical component in dry eye disease, this study was designed to determine if a single eye drop of either Soothe or Systane produces a significant increase in lipid layer thickness (LLT) for subjects reporting symptoms indicative of dry eyes. METHODS: A double-blind, internally paired study was performed. A custom-built lipid layer interferometer, enabling characterization of lipid layer interference patterns, was used to quantify baseline LLT (OU) of eligible subjects. Inclusion criteria included: 1) presence of dry eye symptoms and 2) baseline LLT < or =75 nm. Subjects (n = 40) received a single eye drop of Soothe in one eye and a single eye drop of Systane in the contralateral eye. After the instillation of each test drop, LLT was reanalyzed for all subjects. RESULTS: The mean +/- standard error baseline LLT pre-eye drop instillation was 60.0 +/- 1.8 nm for eyes treated with Soothe and 61.5 +/- 1.8 nm for eyes treated with Systane. These means were not significantly different (p > 0.5). The mean LLT for eyes treated with Soothe increased to 124.4 +/- 4.9 nm (p < 0.0001). The mean LLT for eyes treated with Systane increased to 71.3 +/- 2.6 nm (p < 0.0001). The LLT increase from Soothe was significantly greater than that from Systane (p < 0.0001). CONCLUSIONS: In subjects with symptoms indicative of dry eye states and LLT < or =75 nm, one eye drop of Soothe more than doubled LLT, a 107% mean increase, whereas Systane increased LLT by 16%.

Lid wiper epitheliopathy and dry eye symptoms.

OBJECTIVES: The lid wiper is defined as that portion of the marginal conjunctiva of the upper eyelid that wipes the ocular surface during blinking. The purpose of this study was to investigate whether lid wiper epitheliopathy occurred with patients who reported dry eye symptoms, yet had normal fluorescein breakup time (FBUT) and Schirmer test values and an absence of fluorescein corneal staining. METHODS: One hundred patients were divided into two groups based on the presence or absence of dry eye symptoms, as determined with the Standard Patient Evaluation of Eye Dryness questionnaire. Other criteria for admission to both groups were FBUT of 10 seconds or more, Schirmer test value of 10 mm or more, and absence of fluorescein corneal staining. After instillation of fluorescein and rose bengal dyes, the lid wipers of 50 asymptomatic and 50 symptomatic patients were graded for staining from grade 0 (absent) to grade 3 (severe). RESULTS: Of the symptomatic patients, 76% had staining of the lid wiper: 44%, grade 1; 22%, grade 2; and 10%, grade 3. Of the asymptomatic patients, 12% had staining; 8%, grade 1; 4%, grade 2; and 0%, grade 3. The difference in prevalence of lid wiper staining between the symptomatic and asymptomatic groups was significant (P<0.0001). CONCLUSIONS: Lid wiper epitheliopathy, diagnosed by staining with fluorescein and rose bengal dyes, is a frequent finding when symptoms of dry eye are experienced in the absence of routine clinical dry eye findings.

Lid-wiper epitheliopathy and dry-eye symptoms in contact lens wearers.

PURPOSE: To evaluate whether dry-eye symptoms are associated with epitheliopathy of that portion of the upper eyelid marginal conjunctiva-the lid wiper-that wipes the ocular, or contact lens surface, during blinking. METHODS: Subjects were divided into two groups based on the presence or absence of dry-eye symptoms. The lid wiper of asymptomatic (n=75) and symptomatic (n=30) soft contact lens wearers was examined, following the instillation of fluorescein and rose bengal dyes. Lid-wiper staining was graded zero to 3. RESULTS: Eighty percent of the symptomatic subjects displayed lid-wiper staining compared to 13% of the asymptomatic subjects. The difference in staining between the two groups was significant (P<0.0001). Of the symptomatic subjects, 20% showed no staining; 26.6%, grade 1 staining; 36.6%, grade 2; and 16.6% showed grade 3 staining. Of the asymptomatic subjects, 87% exhibited no staining; 9%, grade 1 staining; 3%, grade 2; and 1% showed grade 3 staining. CONCLUSIONS: This study describes a new clinical condition, lid-wiper epitheliopathy, an alteration of the epithelium of that portion of the marginal conjunctiva of the upper eyelid that wipes the ocular surface, diagnosed by staining with fluorescein and rose bengal dyes.

Quantitative in vitro comparison of fluorescein delivery to the eye via impregnated paper strip and volumetric techniques.

PURPOSE: To compare the quantity of fluorescein delivered to the eye via fluorescein-impregnated paper strips of various sizes and surface areas and via various microliter volumes of fluorescein sodium using an in vitro assay. METHODS: A commercially available fluorescein-impregnated strip (75 mm2) and three modified strips of reduced fluorescein-impregnated surface areas (10, 7.5, and 5.0 mm2) were used. The amount of fluorescein delivered to the eye for each of the four strips was approximated by applying each strip to a Whatman No. 1 filter paper under conditions simulating application of the strip to the eye, extracting the fluorescein from the filter paper in an aqueous solution, and performing spectrophotometric analysis at 484 nm. Similarly, this filter paper analytical system was calibrated using 1, 2, and 3 microl volumes of 2% w/v fluorescein delivered to the filter paper. RESULTS: Using calibration curves, linearity was observed between absorbance and concentration of fluorescein sodium with an R2 value > or = 0.99. Using these calibration curves, the amount of fluorescein delivered to the eye for the four strips and the three fluorescein solution samples was determined. Fluorescein-impregnated strips with surface areas of 75, 10, and 5 mm2 delivered approximately the same quantity of fluorescein to the ocular surface as 3 microl, 1 microl, and 0.5 microl of fluorescein 2% solution, respectively. CONCLUSIONS: The surface area of the fluorescein-impregnated portion of the strip can be designed to control the amount of fluorescein delivered to the eye.