Abstract
Purpose: :
To compare the efficacy and safety of timolol maleate 0.5% with brinzolamide 1% when added to travoprost 0.004% in patients with ocular hypertension or primary open–angle glaucoma.
Methods: :
A prospective, double–masked, randomized, active–controlled, parallel design. Patients at Visit 1 were placed on travoprost dosed every evening for four weeks and then were randomized at baseline (Visit 2) to the addition of timolol maleate or brinzolamide, a safer alternative medication, each given twice daily. Patients returned at Week 4 (Visit 3) for a safety visit and Week 12 (Visit 4) for an efficacy visit. At Visits 2 and 4 the intraocular pressure was measured at 8:00 AM, 12:00 PM and 4:00 PM.
Results: :
Ninety–seven patients completed the study on brinzolamide and 95 on timolol maleate both added to travoprost. The diurnal mean intraocular pressure at Week 12 was 18.1 ± 2.7 mm Hg for brinzolamide and 18.1 ± 3.0 mm Hg for the timolol group. There was no statistical difference found between treatment groups in mean intraocular pressure, or in the reduction in intraocular pressure from baseline, at each time point or for the diurnal curve. intraocular pressure values at the Week 12 visit for timolol and brinzolamide were 19.2 ± 3.6 mm Hg and 19.2 ± 3.3 mm Hg at 8 AM, 17.7 ± 3.3 mm Hg and 17.6 ± 2.8 mm Hg at 12:00 PM and 17.4 ± 3.34 mm Hg and 17.6 ± 3.0 mm Hg at 4:00 PM, respectively. Both medications were well tolerated with the most common adverse event being conjunctival hyperemia in both the brinzolamide and timolol treated patients. There was no significant difference for any adverse event between treatment groups.
Conclusions: :
This study showed that brinzolamide provides equal efficacy and similar topical tolerability compared to timolol when added to travoprost.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure