Transcript Comparison of Bromfenac vs. Ketorolac During the Induction

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
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)
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%)
Greater Improvement in Schirmer’s
Scores with Bromfenac + cyclosporine
Greater Improvement in TBUT with
Bromfenac + cyclosporine
Greater Reduction in Staining with
Bromfenac + cyclosporine
Greater Improvement in OSDI Scores
with Bromfenac + cyclosporine
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.
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).
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.