Maintaining Visual Performance With Topical Cyclosporine Therapy in Patients With Dry Eye: The IMPACT Study

Friday, April 17, 2015
KIOSKS (San Diego Convention Center)
Karl G. Stonecipher, MD
Gail L. Torkildsen, MD
George W. Ousler III
Linda Villanueva, COT
David A. Hollander, MD, MBA

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.