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This multicenter, randomized, double-blind clinical trial was undertaken to compare the intraocular pressure (IOP)-lowering efficacy and safety of topical bimatoprost 0.03% with that of latanoprost 0.005% for the treatment of patients with normal-tension glaucoma. After washout of all ocular hypotensive medications, patients with normal-tension glaucoma (n=60) were randomly assigned to oncedaily bimatoprost 0.03% or latanoprost 0.005% for 3 mo. Diurnal IOP measurements were taken at each study visit. Primary outcome measures consisted of mean change from baseline IOP (8 AM, Noon, 4 PM) and change in visual field. Secondary measures included mean IOP, ophthalmologic examination findings, results of clinical evaluation, and adverse events. Mean change from baseline IOP at each study visit was statistically significant at all diurnal measurements for patients taking bimatoprost and for those taking latanoprost (P<.001). The 8 AM mean change from baseline IOP measurement showed a significant between-group difference (P< or =.033) in favor of bimatoprost at both follow-up visits. After 3 mo of treatment, mean IOP reductions from baseline ranged from 2.8 to 3.8 mm Hg (17.5%-21.6%) with bimatoprost and from 2.1 to 2.6 mm Hg (12.7%-16.2%) with latanoprost. Overall mean reduction in IOP after 3 mo of treatment was 3.4 mm Hg (19.9% rpar; with bimatoprost and 2.3 mm Hg (14.6%) with latanoprost (P=.035). No significant between-group differences were observed in incidence of adverse events, clinical success, or demographic variables. Bimatoprost was found to be more effective than latanoprost in lowering IOP in the patient with normal-tension glaucoma. Both drugs were efficacious and well tolerated.

This month-long multicenter, open-label study evaluated the onset and progression of hyperemia associated with bimatoprost 0.03% once daily in 39 patients with open-angle glaucoma or ocular hypertension. Current glaucoma medication(s) was either replaced with or augmented by bimatoprost. Previous users of bimatoprost were excluded. Primary outcome measures were mean hyperemia scale scores (ciliary, conjunctival, and episcleral, graded on a seven-point scale) and incidence of hyperemia. Secondary outcome measures were fluorescein staining, patient assessment of ocular redness (take-home diary), and patient and investigator evaluations. Patients were asked how troubled they were by their ocular redness. Investigators were asked if they would continue the patient on bimatoprost despite the hyperemia. Overall, the frequency and severity of hyperemia peaked approximately 1 day after the first instillation of bimatoprost and decreased consistently throughout the study, returning to near-baseline levels by day 28. At day 1, 84.6% of patients were hardly troubled or not troubled by their ocular redness; only 15.4% were somewhat or moderately troubled. Investigators indicated that they would continue bimatoprost therapy in 92.3% of the patients. Hyperemia did not represent a significant safety concern.

This review evaluated the clinical evidence of the comparative efficacy and safety of bimatoprost and latanoprost in lowering intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. Four head-to-head, randomized, and controlled clinical trials of bimatoprost and latanoprost with treatment periods ranging from 1 to 6 months were identified from searches of the MEDLINE database through February 2004. According to a review and comparison of the results, bimatoprost, when compared with latanoprost, was associated with greater mean reductions in IOP, greater mean increases in the percentage of patients demonstrating target IOP, and greater response rates. The differences between drugs were not always statistically significant. Overall, the between-group differences in mean IOP ranged from 0 to 1.5 mm Hg. In 92% of the IOP measurements, the mean IOP was lower among patients given bimatoprost than among those given latanoprost; in the remaining 8%, the IOP reduction was equal. Transient, mild conjunctival hyperemia was the most frequently reported adverse effect associated with either drug, but it occurred more frequently with bimatoprost. Overall, both drugs were well tolerated. As a 1-mm Hg change in IOP has been shown to reduce the risk of progression in patients with glaucoma (according to the Early Manifest Glaucoma Trial), the greater efficacy demonstrated by bimatoprost in lowering IOP may be clinically significant.