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Evaluation of Ketorolac (Acular LS) During the Induction Phase of Cyclosporine a (Restasis) Therapy to Improve Patient Comfort

¹ Cornea/External Diseases, Rand Eye Institute, Pompano Beach, FL
² Private Practice, Stony Brook, NY

Commercial Relationships: B.A. Schechter, Allergan C; J.R. Wittpenn, Allergan C.

Support: None.

Abstract

Purpose: Cyclosporine A (Restasis, Allergan) has been proven to effectively relieve the signs and symptoms of dry eye. A small percentage of patients, however, experience stinging with initial use. Since it is imperative to ensure compliance with cyclosporine A therapy to effectively treat dry eye disease and helpful to provide patients with immediate relief of symptoms during the induction phase, the purpose of this study was to determine if use of ketorolac 0.4% (Acular LS, Allergan) improves patient comfort during the initiation of treatment with topical cyclosporine A for the treatment of chronic dry eye disease.

Methods: Single center, randomized, 6–week, open–label clinical trial. Patients with a history of dry eye (n=23) were randomized to cyclosporine A monotherapy or to an adjunctive regimen of ketorolac followed by cyclosporine A instillation 10 minutes later. Study visits were at baseline, week 2, and week 6. Outcome measures included evaluation of corneal staining, ocular comfort on a 4–point scale (1= mild, 4=severe), OSDI and Schirmer scores, and tear break–up time.

Results: After 6 weeks of therapy, the concomitant use of ketorolac with cyclosporine A provided increased ocular comfort compared with cyclosporine A monotherapy. The mean ocular comfort score of the adjunctive patients improved 2.1 points, compared with an improvement of 1.3 points for cyclosporine A alone. The adjunctive regimen also provided significantly greater reductions in corneal staining than cyclosporine A monotherapy, with a mean improvement in staining of 1.9 with adjunctive therapy, compared with 1.4 with monotherapy.

Conclusions: In this small pilot study, the combination of ketorolac with cyclosporine A improved the signs and symptoms of dry eye in the induction phase of cyclosporine A therapy. This induction combination may provide a viable method of increasing compliance and reducing discomfort in patients during the first few weeks of cyclosporine therapy.

Keywords: cyclosporine • cornea: tears/tear film/dry eye

© 2005, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. For permission to reproduce any part of this abstract, contact the ARVO Office at arvo{at}arvo.org.