Maintaining Visual Performance With Topical Cyclosporine Therapy in Patients With Dry Eye: The IMPACT Study
Purpose
To evaluate the efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®, Allergan, Inc., CA) administered twice-daily for 6 months, in the management of ocular surface staining and visual function in patients diagnosed with dry eye disease (DED).
Methods
Single-center, open-label, phase 4 study. Patients with bilateral DED were enrolled if had a score ≥2 in at least 1 DED symptoms assessed (Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire), Ocular Surface Disease Index (OSDI) score >12, and at least 1 eye had Schirmer’s score <10 mm, corneal staining ≥2 and <4 in at least 1 region. Primary endpoints were ocular surface staining and visual function at 6 months. Safety assessments included adverse event reports, visual acuity and biomicroscopy.
Results
Five male subjects (12.5%) and 35 female subjects (87.5%) with a mean subject age of 59.4±9.05 were enrolled in the study. Thirty seven (92.5%) of subjects completed the study. Following 6 months of dosing, there were statistically significant reductions in inferior (p=0.0005), central (<0.0001), and total corneal fluorescein staining (p<0.0001). Subjects also reported statistically significant improvements in OSDI visual function measurements including: 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). All measures of ocular discomfort decreased significantly.
Conclusion
Central corneal staining, specifically, has been clinically recognized as critical to visual function and performance. In this study, following 6 months of dosing, subjects experienced a significant reduction in ocular surface staining which resulted in improved visual performance as measured by the OSDI.