1. Comparison of Bromfenac vs. Ketorolac During the Induction Phase of Treatment with Topical Cyclosporine for Dry Eye Patients Barry A. Schechter, MD Florida Eye Microsurgical Institute Boynton Beach, Florida, USA Consultant for Ista Pharmaceuticals Consultant for Allergan Pharmaceuticals

2. Purpose and Methods PURPOSE Some dry eye patients have discomfort when first initiating cyclosporine therapy. NSAIDs have been shown to be helpful in reducing this discomfort ( Schechter J of Ophthalmic Pharmacology & Therapeutics 2006 April; 22 (2):150-4) We compared the efficacy of ketorolac 0.4% vs. bromfenac 0.09% each when used concomitantly with cyclosporine A for improvement of patient comfort during the induction phase of cyclosporine therapy for dry eye. METHODS Randomized, prospective, single-site study Patients received either bromfenac 0.09% (n=22) or ketorolac (n=21) 10 minutes prior to administering topical cyclosporine twice daily Study visits were at Baseline (Visit 1), Week 2 (Visit 2), and Week 6 (Visit 3)

3. Patient Demographics Mean age of the patients was 60.2 ± 11.7 years in the bromfenac group and 61.4 ± 14.5 years in the ketorolac group (P=.779) 31 of the 43 patients were female (72%)

4. Greater Improvement in Schirmer’s Scores with Bromfenac + cyclosporine

5. Greater Improvement in TBUT with Bromfenac + cyclosporine

6. Greater Reduction in Staining with Bromfenac + cyclosporine

7. Greater Improvement in OSDI Scores with Bromfenac + cyclosporine

8. Patients Reported Greater Comfort with Bromfenac + cyclosporine At Visit 3, patients were asked to rate whether their drop regimen had been comfortable or painful and to rate the severity on a scale of 0 to 3 (where 0=none and 3=very painful). – In the bromfenac group, 17/22 patients reported that the drops were comfortable or not at all painful. – Conversely, in the ketorolac group, only 5/21 patients reported that the drops were comfortable or not at all painful. These differences were statistically significant (P<.001). – In the bromfenac group, only 2/22 (9.1%) of patients reported that they had been experiencing at least mild pain – Conversely, in the ketorolac group, more than half (12/21, 57.1%) reported that they had been experiencing at least mild pain. These differences were statistically significant (P<.001). No other adverse events were reported.

9. Discussion Changes from baseline in Schirmer’s scores, tear break-up time, ocular surface staining, and OSDI scores were improved in both groups of patients. The scores, however, were significantly better with bromfenac than with ketorolac at both follow-up visits (P<.008). More bromfenac patients than ketorolac patients found the drops comfortable (77% vs. 24%, P<.001) and bromfenac patients were less likely than ketorolac patients to report experiencing discomfort (9.1% vs. 57.1%, P<.001).

10. Conclusion In this study, bromfenac + cyclosporine was better tolerated than ketorolac + cyclosporine during treatment induction for dry eye. All dry eye measurements (OSDI,TBUT and Schirmers scores) were better in the bromfenac+cyclosporine group than the ketorolac+cyclosporine group.