Abstract
Abstract: :
Purpose: To compare latanoprost, bimatoprost, and travoprost with regard to intraocular pressure (IOP)-lowering effect and safety in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). Methods: This randomized, parallel-group study was conducted at 45 U.S. sites over 12 weeks. Previously treated OAG or OH patients with an IOP ≥23 mmHg in one or two eyes after washout received latanoprost 0.005%, bimatoprost 0.03%, or travoprost 0.004% once daily (evening). At baseline and Weeks 6 and 12, IOP was measured in triplicate by masked evaluators at 8:00 AM, noon, 4:00 PM, and 8:00 PM, and conjunctival hyperemia was graded by masked investigators before the 8:00 AM IOP measurement. Change between baseline and Week 12 in 8:00 AM IOP measurements (time of peak drug effect) was the primary efficacy outcome. Results: Intent-to-treat analyses included 410/411 randomized patients (latanoprost, 136; bimatoprost 136; travoprost, 138). Baseline mean 8:00 AM IOP levels were similar (P=0.772; approximately 26 mmHg in each treatment group); significant (P<0.001) reductions were observed in all three groups at Week 12. Mean (±SEM) IOP reductions at 8:00 AM were equivalent based on ANCOVA: latanoprost, 8.6±0.3 mmHg; bimatoprost, 8.7±0.3 mmHg; travoprost, 8.0±0.3 (P=0.128). Mean reductions from baseline to Week 12 at noon, 4:00 PM, and 8:00 PM also were not statistically different. Furthermore, plots of the mean reduction of the 3 drugs showed very similar distributions, with few poor responders. Fewer latanoprost-treated patients (53.7%) reported ocular adverse events compared with bimatoprost (73.7%), or travoprost (64.5%) (P<0.001, latanoprost versus bimatoprost). In addition, fewer latanoprost patients reported hyperemia (47.1%, 68.6%, and 58.0%, respectively; P=0.001, latanoprost versus bimatoprost), and severity of hyperemia scores were lower in latanoprost patients at Week 12 (P=0.001, latanoprost versus bimatoprost). Conclusions: Equivalence in the ability to reduce IOP in OAG and OH patients was demonstrated among latanoprost, bimatoprost, and travoprost. Greater ocular tolerability was exhibited by latanoprost.
Keywords: clinical (human) or epidemiologic studies: tre