Original article
Twelve-Month, Randomized, Controlled Trial of Bimatoprost 0.01%, 0.0125%, and 0.03% in Patients with Glaucoma or Ocular Hypertension

https://doi.org/10.1016/j.ajo.2009.12.003Get rights and content

Purpose

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of ophthalmic formulations of bimatoprost 0.01% and 0.0125% compared with bimatoprost 0.03%.

Design

Prospective, randomized, double-masked, multicenter clinical trial.

Methods

Patients with glaucoma or ocular hypertension were randomized to receive once-daily bimatoprost 0.01% (n = 186), bimatoprost 0.0125% (n = 188), or bimatoprost 0.03% (n = 187) for 12 months. The primary efficacy measure was IOP. Safety measures included adverse events and an objective assessment of conjunctival hyperemia.

Results

Baseline mean IOPs were similar among treatment groups. Differences in mean IOP between the bimatoprost 0.01% or 0.0125% groups and the bimatoprost 0.03% group were less than 0.9 mm Hg throughout follow-up. Bimatoprost 0.01%, but not bimatoprost 0.0125%, was equivalent in efficacy to bimatoprost 0.03% based on predetermined criteria (limits of the 95% confidence interval of the between-group difference in mean IOP within ± 1.5 mm Hg at all time points and within ± 1 mm Hg at most time points). The overall incidence of treatment-related adverse events was reduced significantly in the bimatoprost 0.01% and bimatoprost 0.0125% groups compared with the bimatoprost 0.03% group (P ≤ .034). The percentage of patients with a moderate to severe increase from the baseline macroscopic hyperemia score was: bimatoprost 0.01%, 3.2%; bimatoprost 0.0125%, 9.0%; bimatoprost 0.03%, 9.1% (P = .019 for bimatoprost 0.01% vs 0.03%).

Conclusions

Bimatoprost 0.01% was equivalent to bimatoprost 0.03% in lowering IOP throughout 12 months of treatment and demonstrated improved tolerability, including less frequent and severe conjunctival hyperemia. Bimatoprost 0.01% demonstrated a better benefit-to-risk ratio than bimatoprost 0.0125%.

Section snippets

Study Design

This prospective, randomized, multicenter (32 sites in the United States), double-masked, parallel-group, phase 3 study compared bimatoprost 0.01%, bimatoprost 0.0125%, and bimatoprost 0.03% in patients with glaucoma or OHT. The investigators and sites that took part in the study are listed in the Acknowledgments. The study was conducted in accordance with applicable Good Clinical Practice regulations and guidelines.

Study Population

Eligible patients were at least 18 years of age with a diagnosis of OHT,

Patient Characteristics and Disposition

A total of 561 patients were enrolled in the 3 study groups. Patient demographics and clinical characteristics at baseline generally were similar among the treatment groups (Table 1). Patients ranged in age from 23 to 94 years (mean, 63.5 years). Approximately 73% of the patients were white, 14% were black, 57% were female, and 72% required washout of previous ocular hypotensive medication, most commonly a prostaglandin (36%) or bimatoprost (15%). Slightly more than half of the patients (53%)

Discussion

In this study, IOP-lowering efficacy was maintained and tolerability was improved when the concentration of bimatoprost was reduced from 0.03% to 0.01% (or 0.0125%) in the test formulations. All 3 bimatoprost formulations were well accepted by patients and physicians, and all were well tolerated, but the incidence of treatment-related adverse events was statistically and clinically significantly reduced in the bimatoprost 0.01% and 0.0125% groups compared with the bimatoprost 0.03% group, and

L. Jay Katz, MD, FACS, is a Professor of Ophthalmology at Jefferson Medical College and Director of the Glaucoma Service at Wills Eye Institute, Philadelphia, Pennsylvania. He received his MD degree from Yale University Medical School and completed an internship in Internal Medicine at the University of Virginia, a residency in Ophthalmology at Yale, and a Fellowship in Glaucoma at Wills Eye Hospital. He received the 2002 AAO Senior Achievement Award. His research interests include glaucoma.

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  • Cited by (0)

    L. Jay Katz, MD, FACS, is a Professor of Ophthalmology at Jefferson Medical College and Director of the Glaucoma Service at Wills Eye Institute, Philadelphia, Pennsylvania. He received his MD degree from Yale University Medical School and completed an internship in Internal Medicine at the University of Virginia, a residency in Ophthalmology at Yale, and a Fellowship in Glaucoma at Wills Eye Hospital. He received the 2002 AAO Senior Achievement Award. His research interests include glaucoma.

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