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Abstract #15515 Published in IGR 1-3

Efficacy and safety of timolol solution once daily versus timolol gel added to latanoprost

Stewart WC; Day DG; Sharpe ED; Dubiner HB; Holmes KT; Stewart JA
American Journal of Ophthalmology 1999; 128: 692-696


PURPOSE: To compare the efficacy and safety of timolol hemihydrate 0.5% (Betimol, Ciba Vision Ophthalmics, Duluth, GA) versus timolol maleate gel-forming solution 0.5% (Timoptic-XE, Merck, Blue Bell, PA), both given every morning added to latanoprost 0.005% given every evening. METHODS: A multicenter, randomized, crossover comparison was performed in patients with primary open-angle glaucoma or ocular hypertension. After at least a four-week run-in period with latanoprost 0.005% (Xalatan, Pharmacia & Upjohn, Kalamazoo, MI), both eyes of 30 patients (60 eyes) were randomly assigned to one of the two adjunctive therapies, timolol hemihydrate or timolol maleate gel for six weeks. At the end of the first period, the study medicine was discontinued for a two-week washout period. Patients then received the opposite medication for the second six-week period. This study had an 80% power to exclude a 1-mmHg difference between groups. RESULTS: The baseline intraocular pressure after one month of latanoprost treatment only for all 30 subjects was 20.8±2.6 mmHg. After six weeks of timolol hemihydrate, the 24-hour trough intraocular pressure was 17.5±3.4 mmHg, and for timolol maleate gel, 17.9±3.5 mmHg (p=0.74). The peak level two hours after dosing for timolol hemihydrate was 16.4±2.6 mmHg, and for timolol maleate gel, 16.8±3.8 mmHg (P=0.84). No patient was discontinued from the study because of lack of efficacy. No differences were observed between treatments in visual acuity, anterior segment findings, or adverse events. CONCLUSIONS: Once-daily beta-blocker therapy is an effective ocular hypotensive adjunctive treatment 24 hours after dosing when added to latanoprost, for which timolol hemihydrate 0.5% solution and timolol maleate gel 0.5% appear equally effective and safe.

Dr. W.C. Stewart, Pharmaceutical Research Corporation, Charleston, SC 29412-2464; USA


Classification:

11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
11.4 Prostaglandins (Part of: 11 Medical treatment)



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