| Summary: | Karl G Stonecipher,1,2 Gail L Torkildsen,3 George W Ousler III,4 Scot Morris,5 Linda Villanueva,6 David A Hollander6 1Department of Ophthalmology, University of North Carolina, Chapel Hill, 2TLC Laser Eye Centers, Greensboro, NC, 3Andover Eye Associates, 4Ora, Inc., Andover, MA, 5Eye Consultants of Colorado, Conifer, CO, 6Allergan plc, Irvine, CA, USA 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%. Keywords: corneal staining, dry eye disease, Ocular Surface Disease Index, ocular surface staining, visual function, clinical trial
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