Original ArticleComparison of the Ocular Hypotensive Efficacy of Adjunctive Brimonidine 0.15% or Brinzolamide 1% in Combination with Travoprost 0.004%
Section snippets
Study Design Summary
The protocol was approved by the appropriate institutional review boards for each center and followed the tenets of the Declaration of Helsinki. Informed consent was obtained from each patient before study enrollment. The study was posted on the clinicaltrials.gov Web site.
This 3-month randomized, parallel-group, double-masked study was conducted at 18 centers in the United States representing both academic and private practices. After a screening visit, patients began travoprost 0.004%
Results
Two hundred twenty-seven patients from 18 sites were screened, with study centers contributing from 3 patients to 27 patients. Based on the masked analysis, the revised SD was 3 mmHg. Thus, the sample size requirement was revised downward to 70 per group, allowing for 10% overenrollment for dropouts. Due to rapid screening with fewer screen failures toward the end of recruitment, 163 (72%) subjects were randomized: 79 (48.5%) to the brimonidine group and 84 (51. 5%) to the brinzolamide group
Discussion
After adjustment for baseline IOP, the 3-month IOP differences were statistically significant, for the 8 am, 4 pm, and mean diurnal measurements (1.1, 1.0, and 0.7 mmHg, respectively) favoring brinzolamide. The clinical significance of these findings is unclear because the mean differences between groups are small. However, in some individual patients the differences are larger, as demonstrated in the responder analysis.
There was a smaller magnitude of IOP reduction with brimonidine at 8 am and
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Cited by (0)
Manuscript no. 2006-1034.
Supported by an unrestricted grant from Alcon Laboratories, Ft. Worth, Texas (National Eye Institute core grant no. 10608), and grants from Research to Prevent Blindness, New York, New York, and the Hermann Eye Fund, Houston, Texas.
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See “Appendix” (available at http://aaojournal.org) for a list of Study Group members.