The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.

OBJECTIVE: The aim of this study was to evaluate the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. METHODS: This was a single-center, 6-month, open-label, Phase IV study. Patients with bilateral dry eye disease and a symptom score of ≥2 on the Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index score of >12, at least one eye with Schirmer's score <10 mm/5 minutes, and central corneal staining graded as ≥2 on the Ora Calibra™ Corneal and Conjunctival Staining Scale were enrolled. Cyclosporine ophthalmic emulsion 0.05% (Restasis(®)) was instilled twice daily in each eye. The primary efficacy endpoints were ocular surface staining and visual function at 6 months. Secondary outcome measures included Schirmer's test, tear film breakup time, symptoms, and adverse events. RESULTS: A total of 40 patients with the mean age of 59.4 years (range, 40-78 years) were enrolled; 35 (87.5%) were female and 37 (92.5%) completed the study. At 6 months, inferior corneal, central corneal, total corneal, and total ocular surface fluorescein staining were significantly improved from baseline in both eyes (P<0.001). Patient responses on the Ocular Surface Disease Index showed significant improvement in blurred vision and visual function related to reading, driving at night, working with a computer or bank machine, and watching television (P≤0.041). At 6 months, 35.1% of patients achieved ≥5 mm improvement and 18.9% achieved ≥10 mm improvement in the average eye Schirmer score. Mean tear film breakup time improved by >50% in both eyes (P>0.001). Patients reported significant improvement in ocular discomfort and dry eye symptoms (P<0.001). No patients discontinued treatment because of stinging or any other ocular adverse event. CONCLUSION: Dry eye patients with difficulties with day-to-day visual function demonstrated improvement in both signs and symptoms of dry eye and reported improved visual function after 6 months of treatment with cyclosporine ophthalmic emulsion 0.05%.

Epinastine 0.05% ophthalmic solution in contact lens-wearing subjects with a history of allergic conjunctivitis.

OBJECTIVES: To assess the comfort and efficacy of epinastine 0.05% ophthalmic solution in contact lens wearers with a history of allergic conjunctivitis and contact lens intolerance during allergy season. METHODS: One hundred forty-six subjects were enrolled in a multicenter, open-label study. Enrolled subjects instilled rewetting drops twice a day for a one-week run-in period, then were randomized to epinastine 0.05% twice a day plus rewetting drops as required (n = 75) or rewetting drops alone as required (minimum use twice a day) (n = 71). Subjects recorded the length of time that contact lens wear was comfortable, the total time of wear, ocular itch, overall comfort, and use of rewetting drops during the run-in period, at baseline, and on days 2 to 7 of the treatment period. RESULTS: Subjects averaged 34 years of age; 79% were female. No significant differences were shown at baseline between subjects treated with epinastine 0.05% twice a day plus rewetting drops and control subjects treated with rewetting drops alone. Averaged over the treatment period, epinastine provided significant increases in comfortable wearing time (1.33 +/- 2.89 vs. 0.43 +/- 2.28 hr, P=0.012) and total wearing time (0.35 +/- 1.87 vs. -0.32 +/- 1.81 hr, P=0.008) compared with controls. Epinastine users reported less frequent additional rewetting drop use on average by 0.56 uses per day, which was significantly different than controls (reduction of 0.06 uses per day; P=0.012). Epinastine provided significantly greater improvements from baseline in ocular itch and overall eye comfort compared with rewetting drops alone (P