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Abstract #9906 Published in IGR 5-3
A six-week, parallel, randomized, double-blind study comparing the efficacy and safety of the 0.5% timolol/2.0% MK-507 combination b.i.d. to the concomitant administration of 0.5% timolol b.i.d. and 2.0% MK-507 b.i.d.
Chen YF; Yang CH; Hung PTJournal of Ocular Pharmacology and Therapeutics 2003; 19: 417-423
This was a six-week, parallel, randomized, double-blind study comparing the efficacy and safety of the 0.5% timolol/2.0% MK-507 combination b.i.d. to the concomitant administration of 0.5% timolol b.i.d. and 2.0% MK-507 b.i.d. Patients with ocular hypertension or open-angle glaucoma aged from 21-85 years were enrolled in the study. Each of them should have intraocular pressure (IOP) of 20 mmHg or more in the study eye after they completed the wash-out period. The patients enrolled were randomly assigned to either combination (0. 5% timolol/2.0% MK-507 b.i.d. and placebo b.i.d.) or concomitant (0.5% timolol b.i.d. and 2.0% MK-507 b.i.d.) treatment. During the study, no systemic or topical medication affecting IOP other than the test drugs was allowed. A total of 20 randomized patients were included in the intention-to-treat population for analysis of data. Ten were assigned to the combination treatment, the remainder to the concomitant treatment. There was no statistically significant difference between the two study treatments in terms of gender distribution, average age, and average IOP at the trough and the peak before starting the test medications. Mean reduction of IOP from baseline to the final visit at the trough was 5.04 mmHg in the combination treatment and was 2.73 mmHg in the concomitant treatment group. Mean reduction of IOP at the peak was 2.19 mmHg in the combination treatment and 2.53 mmHg in the concomitant treatment group. There were no statistically significant differences in the above analyses between the two treatment groups. Safety evaluation was carried out, and the number of adverse events in each treatment group did not differ substantially. Ocular signs and symptoms were evaluated at each visit, and none of the between-treatment values differed significantly. Laboratory tests were performed, and showed no significant differences between pre- and post-treatment periods. None of these was found to be clinically serious. The authors concluded that the 0.5% timolol/2.0% MK-507 combination b.i.d. is equivalent in its efficacy to lower IOP as well as in its safety compared to the concomitant administration of 0.5% timolol b.i.d. and 2.0% MK-507 b.i.d. in patients with ocular hypertension or open-angle glaucoma.
Dr. P.T. Hung, Department of Ophthalmology, National Taiwan University Hospital, No. 7, Chung-Shan South Road, Taipei, Taiwan
Classification:
11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
11.5.2 Topical (Part of: 11 Medical treatment > 11.5 Carbonic anhydrase inhibitors)
