Efficacy and safety of timolol solution once daily vs timolol gel added tolatanoprost

PURPOSE: To compare the efficacy and safety of timolol hemihydrate 0.5% (Be timol, Ciba Vision Ophthalmics, Duluth, Georgia) vs timolol maleate gel-for ming solution 0.5% (Timoptic-XE, Merck, Blue Bell, Pennsylvania), both give n every morning added to latanoprost 0.005% given every evening. METHODS: A multicenter, randomized, crossover comparison was performed in p atients with primary open-angle glaucoma or ocular hypertension. After at l east a 4-week run-in period with latanoprost 0.005% (Xalatan, Pharmacia & U pjohn, Kalamazoo, Michigan), both eyes from 30 patients (60 eyes) were rand omly assigned to one of the two adjunctive therapies, timolol hemihydrate o r timolol maleate gel for 6 weeks. At the end of the first period, the stud y medicine was discontinued for a 2-week washout period. Patients then rece ived the opposite medication for the second 6-week period. This study had a n 80% power to exclude a 1-mm Hg difference between groups. RESULTS: The baseline intraocular pressure after 1 month of latanoprost tre atment only for all 30 subjects was 20.8 +/- 2.6 mm Hg. After 6 weeks of ti molol hemihydrate, the 24-hour trough intraocular pressure was 17.5 +/- 3.4 mm Hg, and for timolol maleate gel, 17.9 +/- 3.5 mm Hg (P = .74). The peak level 2 hours after dosing for timolol hemihydate was 16.4 +/- 2.6 mm Hg, and for timolol maleate gel, 16.8 +/- 3.8 mm Hg (P = .84). No patient was d iscontinued from the study be cause of lack of efficacy. No differences wer e observed between treatments in visual acuity, anterior segment findings, or adverse events. CONCLUSIONS: Once-daily beta-blocker therapy is an effective ocular hypoten sive adjunctive treatment 24 hours after dosing when added to latanoprost, for which timolol hemihydrate 0.5% solution and timolol maleate gel 0.5% ap pear equally effective and safe. (C) 1999 by Elsevier Science Inc. All righ ts reserved.