Fort Lauderdale, FL—Ketorolac tromethamine 0.4% ophthalmic solution (Acular LS, Allergan) may be a useful adjunct for improving patient comfort and treatment compliance during the induction phase of dry eye therapy with cyclosporine 0.05% ophthalmic emulsion (Restasis, Allergan), Barry A. Schechter, MD, said to colleagues at the annual meeting of the Association for Research in Vision and Ophthalmology here.
Dr. Schechter, director, department of corneal and external diseases, Rand Eye Institute, Pompano Beach, FL, reported the results of a 6-week, open-label pilot study in which 52 patients were randomly assigned to twice-a-day treatment with cyclosporine alone or with concurrent use of ketorolac administered 10 minutes prior to the cyclosporine. At evaluations performed 2 and 6 weeks after treatment, patients using ketorolac experienced greater improvements in ocular comfort and corneal staining.
"Cyclosporine is very effective for relieving the signs and symptoms of dry eye, but stinging upon instillation that occurs particularly when in-itiating its use may lead to noncompliance," Dr. Schechter said. "Consequently, patients may become discouraged early on because it may take several weeks before symptomatic improvement.
The patients enrolled in the comparative study had a clinical diagnosis of dry eye, were judged by the investigator to be good candidates for cyclosporine therapy, and were 18 years of age or older. There were no statistically significant differences between treatment groups in their demographic characteristics. The patients had a mean age of about 67 years, nearly three-fourths were female, and the majority (81%) were Caucasian.
Subjective ocular comfort was self-rated by the patients using a 4-point scale (1 = mild discomfort, 4 = severe discomfort). Both groups showed a statistically significant reduction (improvement) in the mean ocular comfort score by 2 weeks and further improvement at 6 weeks. However, the improvement was greater in the combination group compared with cyclosporine monotherapy at week 2 (–0.67 versus –0.89, respectively) and week 6 (–2.55 versus –1.53, respectively), and the difference in improvement at 2 weeks was statistically significant favoring cyclosporine/ketorolac.
Objective corneal staining evaluations showed early, statistically significant improvements from baseline with both cyclosporine monotherapy (–1.07) and combination treatment (–1.39) and greater benefit with each regimen at study conclusion (cyclosporine –1.27; cyclosporine/ketorolac –1.74). The difference between treatment protocols achieved statistical significance at 6 weeks.
Conclusion from study
At the study conclusion, mean improvement in the ocular surface disease index (OSDI) score (an FDA-approved questionnaire used to evaluate dry eye symptoms) was also greater in the cyclosporine/ketorolac group compared with cyclosporine monotherapy (–23.85 versus –15.03, respectively), and there was a trend toward statistical significance for the difference. Schirmer test scores and tear break-up time values were also assessed and found to be improved during the study in both groups, but there was no statistically significant difference between groups in the changes from baseline at either 2 or 6 weeks.
Dr. Schechter also noted that no adverse events occurred with the use of ketorolac over the 6 weeks of the study.