Background: Bimatoprost 0.03% has been shown to consistently reduce mean intraocular pressure (IOP) more than timolol 0.5% over 2 years. To further evaluate long-term safety and efficacy, once-daily bimatoprost 0.03% was compared with timolol 0.5% twice daily through year 4.
Methods: In this multicentre, double-masked, randomised, controlled trial, glaucoma and ocular hypertension patients (n = 152) who completed phase III bimatoprost trials through month 36 were enrolled in a study extension through month 48. Patients randomised to bimatoprost once daily (n = 78) or timolol twice daily (n = 35) continued on the same regimen for a fourth year. Patients randomised to bimatoprost twice daily had been switched to bimatoprost once daily dosing at month 24 (bimatoprost twice daily/once daily treatment group), and continued with once daily dosing through month 48 (n = 39). IOP was measured at 08:00 and 10:00 at months 39, 42, 45 and 48. Safety measures included adverse events, biomicroscopy, ophthalmoscopy, visual acuity and visual field.
Results: Baseline IOP was comparable among groups. During year 4, mean IOP reductions from baseline were 7.0 to 8.1 mm Hg with bimatoprost once daily and 6.5 to 7.9 mm Hg with bimatoprost twice daily/once daily, significantly greater than with timolol twice daily (3.8 to 5.8 mm Hg, p⩽0.035) at all measurements. Over 4 years, the mean IOP reduction from baseline at 08:00 and 10:00 was 1.9 to 3.9 mm Hg (35% to 100%) greater with bimatoprost once daily than with timolol (p⩽0.013). Low IOPs were achieved by more bimatoprost than timolol patients (p⩽0.042). No safety concerns developed during long-term bimatoprost treatment; two patients in the timolol treatment group discontinued after month 36 because of adverse events. The most common treatment-related adverse event in the bimatoprost treatment groups was conjunctival hyperaemia.
Conclusion: Bimatoprost once daily provided sustained IOP lowering greater than timolol twice daily and was well tolerated over long-term use.
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Preliminary results of this study were presented at the American Glaucoma Society Annual Meeting, 3–6 March 2005, Snowbird, UT, and the American Society of Cataract and Refractive Surgery/American Society of Ophthalmic Administrators (ASCRS/ASOA) 2005 Symposium & Congress; 15–20 April 2005, Washington, DC.
Funding: This study was sponsored by Allergan, Inc., Irvine, CA.
Competing interests: RDW, JSC and RLG have no proprietary interest in bimatoprost or Allergan, Inc. CCL, ES and ALB are employed by Allergan, Inc. Allergan, Inc. was involved in study design, monitoring data collection, data analyses and writing of the manuscript, and approved the submission of the manuscript for publication.
Ethics approval: Ethics approval was obtained from Institutional Review Board, Cincinnatti Eye Institute; Institutional Review Board for Human Subject Research, Baylor College of Medicine; IUPUI and Clarian Institutional Review Boards; University of Arizona Health Sciences Center, Human Subjects Committee; Human Research Advisory Committee, University of Arkansas for Medical Sciences; and Western Institutional Review Board.
Patient consent: Obtained.