1. Ocular hypotensive efficacy and safety of travoprost 0.004% in inadequately controlled primary open-angle glaucoma or ocular hypertension: short-term, multicenter, prospective study.
- Author
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Blini M, Rossi GC, Trabucchi G, Curatola MR, David A, Radaelli R, Merlo G, and Ratiglia R
- Subjects
- Aged, Cloprostenol administration & dosage, Cloprostenol pharmacology, Cloprostenol therapeutic use, Female, Glaucoma, Open-Angle physiopathology, Humans, Intraocular Pressure drug effects, Male, Middle Aged, Ocular Hypertension physiopathology, Prospective Studies, Travoprost, Treatment Outcome, Cloprostenol analogs & derivatives, Glaucoma, Open-Angle drug therapy, Ocular Hypertension drug therapy
- Abstract
Objective: To evaluate the intraocular pressure (IOP) lowering efficacy and safety of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension, poorly controlled with or intolerance to beta-blockers. To record the short-term effect on diastolic ocular perfusion pressure (DOPP)., Research Design and Methods: One hundred and three patients with open-angle glaucoma or ocular hypertension were treated with travoprost 0.004% once daily for 90 days in an open-label, non-controlled study. Efficacy and safety were assessed at baseline, after 45 and 90 days. Clinical registry number IT0301., Main Outcome Measures: The primary outcome measure, IOP, was recorded at 10 am, 12 pm, and 4 pm at each visit. DOPP was evaluated at 10 am, at baseline and visit 3. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure., Results: Mean IOP was reduced from 22.2 +/- 1.7 mmHg to 16.5 +/- 2.1 after 45 days (p < 0.0001), and to 16.1 +/- 2.2 after 90 days (p < 0.0001). The DOPP increased by 5.3 +/- 6.3 mmHg after 90 days of treatment (p < 0.0001). No drug related serious adverse events were reported during the study., Conclusions: The open-label and non-comparative nature of the study represented its principal limitations. The study confirmed the efficacy and tolerability of travoprost in the treatment of open-angle glaucoma or ocular hypertension, in a subset of patients unsuccessfully treated with beta-blockers. In this study, travoprost significantly increased DOPP at short-term follow-up. Further studies to assess the effect of travoprost on DOPP are warranted.
- Published
- 2009
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