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I. Goldberg, J. G. Crowston, B. Cvenkel, M. C. Jasek, J. A. Stewart, W. C. Stewart, ADAPT Study Investigator Group; Intraocular Pressure-Lowering Efficacy of Brinzolamide Compared With Placebo When Added to Travoprost/Timolol Fixed Combination as Adjunctive Therapy in Primary Open-Angle Glaucoma or Ocular Hypertensive Patients. Invest. Ophthalmol. Vis. Sci. 2010;51(13):165.
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This study compared the efficacy of brinzolamide (BRZ) versus placebo added to travoprost/timolol fixed combination (TTFC) in patients with ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
This was a prospective, double-masked, randomized, placebo-controlled, parallel study.Uncontrolled patients treated with a prostaglandin based mono- or adjunctive therapy were changed to a TTFC regimen given each morning for 4 weeks. Patients whose intraocular pressure (IOP) was 19 to 32 mm Hg (inclusive) at 08:00 underwent additional measurements at 12:00 and 16:00. Patients were then randomized to receive either placebo or BRZ given twice daily, in addition to TTFC for 12 weeks. At the end of the 12 week period, IOP measurements were repeated.
There were 75 and 78 patients in the BRZ and placebo arms, respectively for the per protocol analysis. The mean diurnal IOP was reduced from 20.3±2.0 to 17.5±2.6 mm Hg in the BRZ group and from 20.9±2.7 to 19.4 ± 3.8 mm Hg in the placebo group. IOP was significantly lower in the BRZ group for the 08:00, 16:00, and mean diurnal time points when compared to the placebo group(P≤0.014).There were 30 adverse events in the placebo group and 24 in the BRZ group. There was no statistical difference in the adverse events observed between treatment groups (P=0.47).
This study demonstrated that BRZ may be safely added as an adjunct to TTFC therapy and provide further significant reduction in IOP in patients with OHT or POAG. Additionally, this study found that BRZ provided an additional IOP-lowering of about 14% compared to the starting IOP on the fixed combinationClinical trial registration - NCT00382226
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