A COMPARISON OF THE INTRAOCULAR PRESSURE LOWERING EFFECT OF COSOPT® TO THE CONCOMITANT ADMINISTRATION OF ALPHAGAN® AND TIMOLOL.

Lisa Johnson-Pratt

Abstract

PURPOSE. To compare peak and trough intraocular pressure (IOP) lowering effect of Cosopt® b.i.d. to the concomitant administration of Alphagan® + timolol b.i.d. after 3 and 6 months.

METHOD. This was a randomized, multicenter, observer-masked, parallel-group study of patients with ocular hypertension or primary open-angle glaucoma. Following an open-label 3-week timolol b.i.d. run-in period, 293 patients with a peak IOP of >22 mmHg were randomized to receive either Cosopt, 1 drop b.i.d., or Alphagan+timolol, 1 drop of each solution b.i.d., for 6 months. Adjusted mean (SE) changes from randomization in peak and trough IOP were compared at 3 and 6 months. Equivalence was defined as IOP lowering effects +/- 1.5 mmHg between treatments.

RESULTS. At 3 months, the Cosopt (C) group had a change in peak IOP of-5.04 (0.30) mmHg vs.-5.41 (0.30) in the Alphagan+timolol (A+t) group. The treatment difference at peak was 0.36 (0.40) mmHg; (95% confidence interval (CI)-0.42 to 1.14). At trough, the C group had a change in IOP of-3.66 (0.29) mmHg vs.-4.15 (0.28) in the A+t group. The treatment difference at trough was 0.49 (0.39) mmHg; (95% CI-0.27 to 1.25). At 6 months, the C group had a change in peak of-4.59 (0.29) mmHg vs.-5.07 (0.29) in the A+t group. The treatment difference at peak was 0.48 (0.39) mmHg; (95% CI-0.29 to 1.25). At trough, the C group had a change in IOP of-3.12 (0.28) mmHg vs. -3.82 (0.27) in the A+t group. The treatment difference at trough was 0.70 (0.37) mmHg; (95% CI-0.04 to 1.43). Discontinuations due to adverse experiences were similar between groups.

CONCLUSIONS. Peak and trough IOP lowering effects of Cosopt were comparable to the concomitant administration of Alphagan and timolol after 3 and 6 months. Both treatments were generally well tolerated.

Details

Year: 2001

Program Number: 4:00 pm

Author Affiliation: Merck & Co., Inc.

Co-Authors: Janet Serle, Adam Polis, Paul DeLucca, Andrea Kolodny, Charlena Fletcher, Deborah Cassel, Denise Boyle, Franck Skobieranda

Co-Author Affiliation: Merck & Co., Inc., Merck & Co., Inc., Merck & Co., Inc., Merck & Co., Inc., Merck & Co., Inc., Merck & Co., Inc., Merck & Co., Inc., Merck & Co., Inc.

Room: Room103