Elsevier

Ophthalmology

Volume 114, Issue 7, July 2007, Pages 1248-1254.e2
Ophthalmology

Original Article
Comparison of the Ocular Hypotensive Efficacy of Adjunctive Brimonidine 0.15% or Brinzolamide 1% in Combination with Travoprost 0.004%

Presented in part at: American Glaucoma Society Annual Meeting, March 2006, Charleston, South Carolina, and Association for Research and Vision in Ophthalmology Annual Meeting, April 2006, Fort Lauderdale, Florida.
https://doi.org/10.1016/j.ophtha.2007.03.012Get rights and content

Purpose

To compare efficacies of adjunctive therapy with brimonidine 0.15% and adjunctive therapy with brinzolamide 1% in combination with travoprost 0.004%.

Design

Three-month randomized, parallel-group, double-masked, multicenter clinical trial.

Participants

Patients with primary open-angle glaucoma, exfoliation glaucoma, or ocular hypertension with intraocular pressure (IOP) > 18 mmHg on monotherapy with travoprost (N = 163).

Methods

Patients were randomized to receive adjunctive therapy with twice-daily brimonidine (N = 79) or twice-daily brinzolamide (N = 84). Treatment efficacy was assessed after 1 and 3 months of combination therapy. Intraocular pressure was measured at 8 am, noon, and 4 pm at baseline (on travoprost monotherapy) and after 3 months of combination therapy. Mean diurnal IOP was defined as the average of the IOP measurements at these 3 time points. Adverse events were recorded at each visit.

Main Outcome Measure

Difference between treatment groups in mean diurnal IOP at month 3, adjusted for difference in baseline IOP, using analysis of covariance.

Results

Mean diurnal IOPs (± standard error of the mean) at baseline were 21.7±0.33 mmHg in the brimonidine group and 21.1±0.29 mmHg in the brinzolamide group (P = 0.16). Mean diurnal IOPs at month 3 were 19.6±0.41 mmHg in the brimonidine group and 18.4±0.33 mm Hg in the brinzolamide group (P = 0.019). At month 3, mean diurnal IOPs, adjusted for difference in baseline IOP, were 19.3±0.27 in the brimonidine group and 18.6±0.25 in the brinzolamide group (P = 0.035).

Conclusions

The combination of travoprost and brinzolamide was statistically significantly more efficacious than the combination of travoprost and brimonidine in lowering IOP. The clinical significance of this difference is uncertain.

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

References (21)

There are more references available in the full text version of this article.

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.

See “Appendix” (available at http://aaojournal.org) for a list of Study Group members.

View full text