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S Melamed, I Bossawska, C LarochBimatoprost Adjunctive to Timolol Study Group; Effectiveness of Bimatoprost (LUMIGAN) as Adjunctive Therapy with Topical Beta-blockers in Patients with Glaucoma or Ocular Hypertension: A 3-Month, Multi-center, Double-masked, Randomized, Vehicle-controlled Trial with Double-masked Extension of Bimatoprost Treatment to 1 Year . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1068.
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Purpose:To evaluate the efficacy and safety of bimatoprost 0.03% as adjunctive therapy with beta-blockers in glaucoma or ocular hypertension patients with high intraocular pressure (IOP) inadequately controlled by beta-blocker monotherapy. Methods:This was a 3 month, multicenter, double-masked, randomized, vehicle-controlled, parallel-group clinical trial with double-masked study extension for active medication to 1 year. For the initial 3 month study, patients with high IOP after at least 2 weeks of beta-blocker monotherapy were randomly assigned to adjunctive treatment with bimatoprost QD (n=93), bimatoprost BID (n=97), or vehicle (n=95). In the 9 month masked extension, patients on bimatoprost continued their regimens, while patients in the vehicle group were randomly assigned to treatment with bimatoprost QD, or BID. IOP and safety were evaluated at prestudy, day 0(baseline), and 4 follow-up visits in each treatment phase. Results:After 3 months of treatment, bimatoprost/beta blocker QD reduced the mean IOP from beta-blocker treated baseline at 8 AM by 7.4 mm Hg (31%). Bimatoprost QD dosing was preffered over BID dosing because it had fewer side effects. When vehicle/beta blocker patients were switched to bimatoprost/beta-blocker, IOP was reduced to levels that were comparable to the continuously treated bimatoprost groups. After one year of treatment, the bimatoprost QD group achieved a mean IOP reduction from baseline at 8 AM of 8 mmHg(33%). The most common side effects were conjunctival hyperemia and growth of eyelashes Conclusion:Bimatoprost QD adjunctive therapy with beta-blockers was safe and effective, providing significant long-term additional IOP lowering in patients inadequately controlled on beta-blocker monotherapy
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