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


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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.

Additivity Study GroupRobert M. Feldman, MD12Corresponding Author Informationemail address, Angelo P. Tanna, MD3, Ronald L. Gross, MD4, Alice Z. Chuang, PhD1, Laura Baker, BA2, Adam Reynolds, MD5, Thomas C. Prager, PhD, MPH12

Received 12 September 2006; accepted 7 March 2007. published online 16 May 2007.

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.

1 Department of Ophthalmology and Visual Science, University of Texas Medical School, Houston, Texas.

2 Hermann Eye Center, Houston, Texas.

3 Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

4 Department of Ophthalmology, Baylor College of Medicine, Houston, Texas.

5 Dean McGee Eye Institute, University of Oklahoma, Oklahoma City, Oklahoma.

Corresponding Author InformationCorrespondence to Robert Feldman, MD, 6411 Fannin, 7th Floor Jones, Houston, TX 77030.

 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.

PII: S0161-6420(07)00237-0

doi:10.1016/j.ophtha.2007.03.012


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