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Abstract #6181 Published in IGR 2-2
Long-term intraocular pressure-lowering efficacy and safety of timolol maleate gel-forming solution 0.5% compared with timoptic XE 0.5% in a 12-month study
Schenker HI; Silver LHAmerican Journal of Ophthalmology 2000; 130: 145-150
PURPOSE: To evaluate the long-term intraocular pressure- (IOP) lowering efficacy and safety of timolol maleate gel-forming solution 0.5% (timolol GFS 0.5%, Alcon Research Ltd., Fort Worth, TX) compared with timoptic XE 0.5% (Merck, Inc., West Point, PA) in patients with open-angle glaucoma or ocular hypertension. METHODS: Two hundred and forty-one patients with open-angle glaucoma or ocular hypertension, who had IOP of between 22 and 36 mmHg in at least one eye, were randomly assigned in a 2:1 ratio to receive either timolol GFS 0.5% once daily or timoptic XE 0.5% once daily, in a 12-month, randomized, multicenter, double-masked, prospective study. The primary efficacy variable was mean trough IOP measured at 8.00 a.m., approximately 24 hours after dosing. RESULTS: The timolol GFS 0.5% group produced significant trough IOP reductions from a baseline of 4.5 to 5.2 mmHg (p = 0.0001), compared with reductions of 4.1-5.3 mmHg (p = 0.0001) in the timoptic XE 0.5% group. The difference in mean IOP between the two treatments was 0.9 mmHg or less, and the upper 95% confidence limit between groups was 0.92 mmHg or less at all time points, demonstrating both clinical and statistical equivalence. A similar percentage of patients in the timolol GFS 0.5 group (71%) and in the timoptic XE group (72%) had clinically relevant reductions in IOP. There was no significant difference in the safety profiles of the two treatments. CONCLUSIONS: Both treatments were clinically effective in lowering IOP and maintaining the reductions over long-term use. Timolol GFS 0.5% is a safe and effective therapy for open-angle glaucoma or ocular hypertension and is both clinically and statistically equivalent to timoptic XE 0.5% in reducing IOP.
Dr. L.H. Silver, Alcon Research Ltd., 6201 South Freeway, R5-10, Fort Worth, TX 76134, USA. lewis.silver@alconlabs.com
Classification:
11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
