Intraocular pressure-lowering efficacy of brinzolamide when added to travoprost/timolol fixed combination as adjunctive therapy.

Abstract

PURPOSE:

To compare the efficacy of brinzolamide versus placebo when added to travoprost/timolol fixed combination (TTFC) in uncontrolled patients.

PATIENTS AND METHODS:

This was a prospective, double-masked, randomized, placebo-controlled, parallel comparison of ocular hypertensive or primary open-angle glaucoma patients. Patients treated with a prostaglandin-based mono or adjunctive therapy were changed to TTFC qam (every day dosing) for 4 weeks. Patients with an intraocular pressure (IOP) of 19 to 32 mm Hg at 08:00 hours underwent additional measurements at 12:00 and 16:00 hours. Patients were then randomized to either placebo or brinzolamide given twice daily in addition to TTFC. At week 12, patients had their IOP measurements repeated.

RESULTS:

The per protocol dataset consisting of 78 placebo and 75 brinzolamide-treated patients decreased mean diurnal IOP (mm Hg) as well as IOP at all 3 individual time points (P≤0.005). Brinzolamide reduced the mean diurnal IOP from 20.3±2.0 to 17.5±2.6, whereas placebo reduced IOP from 20.9±2.7 to 19.4±3.8. The mean diurnal IOP was reduced from baseline and for the 08:00 and 16:00 hours time points in the brinzolamide group compared with placebo (P≤0.014). There were 30 adverse events with placebo and 24 with brinzolamide (intent-to-treat). There was no statistical difference for the side-effect profile observed between the treatment groups (P=0.47).

CONCLUSIONS:

This study suggests that brinzolamide may be safely added to TTFC therapy to provide further significant reduction in IOP patients with ocular hypertensive or primary open-angle glaucoma.

• Authors: Ivan Goldberg, Jonathan G Crowston, Mark C Jasek, Jeanette A Stewart, William C Stewart, ADAPT Study Investigator Group
• Journal: Journal of glaucoma (J Glaucoma) Vol. 21 Issue 1 Pg. 55-9 (Jan 2012) ISSN: 1536-481X [Electronic] United States
• PMID: 21048504 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Drug Combinations
• Ophthalmic Solutions
• Sulfonamides
• Thiazines
• Cloprostenol
• Timolol
• brinzolamide
• Travoprost

Topics

• Aged
• Antihypertensive Agents (administration & dosage, adverse effects)
• Cloprostenol (administration & dosage, adverse effects, analogs & derivatives)
• Double-Blind Method
• Drug Combinations
• Female
• Glaucoma, Open-Angle (drug therapy, physiopathology)
• Humans
• Intraocular Pressure (drug effects, physiology)
• Male
• Middle Aged
• Ocular Hypertension (drug therapy, physiopathology)
• Ophthalmic Solutions (administration & dosage, adverse effects)
• Prospective Studies
• Sulfonamides (administration & dosage, adverse effects)
• Thiazines (administration & dosage, adverse effects)
• Timolol (administration & dosage, adverse effects)
• Tonometry, Ocular
• Travoprost
• Treatment Outcome
• Visual Acuity