24-hour IOP control with once-daily bimatoprost, timolol gel-forming solution, or latanoprost: A 1-month, randomized, comparative clinical trial

Purpose: To compare the efficacy and safety of once-daily (QD) bimatoprost, latanoprost, and timolol gel-forming solution in providing 24-hour intraocular pressure (TOP) control. Design,: This was a randomized, multicenter, investigator-masked, prospective, parallel-group, clinical trial. Participants: Patients with open-angle glaucoma or ocular hypertension. Intervention: After washout of any previous ocular hypotensive medications, patients were randomly assigned to treatment with bimatoprost 0.03% ophthalmic solution QD (n = 38) or latanoprost 0.005% ophthalmic solution QD (n = 38) between 7 and 9 PM, or timolol maleate 0.5% gel-forming ophthalmic solution QD (n = 39) between 7 and 9 AM for 1 month. Main outcome measures: The primary outcome measure, circadian IOP, was measured at eight time points over the course of 24 hours beginning at 8 AM on day 28 and with the last measurement at 8 AM on day 29. IOP was also measured at 8 Am and 10 Am at baseline and at 8 AM on day 14. Safety measures included adverse events, biornicroscopy, visual acuity, heart rate, and blood pressure. Results: At 10 AM (peak drug effect) on day 28, the mean IOP reduction from baseline was significantly greater with bimatoprost (9.3 nim Hg, 40.3%) than with timolol gel (7.1 min Hg, 31.1 %; P =.024, Wilcoxon rank sum test) or latanoprost (7.4 mm Hg, 33.3%). In the overall analysis of IOP measured over the course of 24 hours, mean IOP was significantly lower with bimatoprost or laLanoprost than with timolol gel (P < .001; analysis of repeated measures). The analysis of repeated measures also showed a significant difference between bimatoprost and latanoprost (P =.003). In the area-under-the-curve analysis, bimatoprost and latanoprost were superior to timolol gel (P less than or equal to .018) but comparable to each other (P greater than or equal to .223). All treatment regimens were well tolerated, with few discontinuations due to adverse events. There were no significant effects on systemic safety parameters. Conclusion: Once-daily bimatoprost or latanoprost provided significantly better 24-hour IOP control than timolol gel in patientswith glaucoma orocular hypertension. Some measurements suggested a trend for greater efficacy of bimatoprost over latanoprost. All three treatments were well tolerated. (Surv Ophthalmol 49(Suppl 1):S26-S35, 2004. (C) 2004 Elsevier Inc. All rights reserved.).