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Gail Torkildsen, Karl Stonecipher, George W Ousler, Linda Villanueva, David A Hollander; An investigation of 0.05% cyclosporine ophthalmic emulsion in reducing ocular surface staining and impact on visual performance in individuals with dry eye.. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4479.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the clinical correlation between ocular surface staining and visual function in dry eye subjects receiving cyclosporine 0.05% ophthalmic emulsion. (Restasis®, Allergan, Inc., CA).
In this single-center, open-label, 3-visit study, dry eye patients were administered Restasis® twice-daily for 6 months. Patients were included in the study if they at least 1 of the 5 symptoms of the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index (OSDI) score >12, and presence of corneal staining. Primary efficacy endpoints were ocular surface staining and visual performance at 6 months.
Forty subjects were enrolled in the study. Five subjects were male (12.5%) and 35 subjects were female (87.5%); mean subject age was 59.4±9.05. Thirty seven (92.5%) of subjects completed the study and were considered in the per protocol population. At 6 months, there were statistically significant reductions in inferior (p=0.0005), central (<0.0001), and total corneal staining (p<0.0001). Additionally, subjects reported statistically significant improvements in visual function as measured by the OSDI for blurred vision (p=0.0044), poor vision (p=0.0377), reading (p=0.0007), driving at night (p=0.0407), working with a computer (p<0.001), and watching television (p=0.0002).
The reduction in ocular surface staining resulted in an improvement in visual performance as measured by the OSDI. The significant reduction in central staining, specifically, is clinically relevant as the central cornea is critical to visual function.
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