A randomized trial in patients inadequately controlled with timolol alone comparing the dorzolamide-timolol combination to monotherapy with timolol or dorzolamide 1☆
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Received 7 November 1997; accepted 21 May 1998.
Abstract
Objective
To compare the dorzolamide-timolol fixed combination twice daily to its components, timolol maleate and dorzolamide hydrochloride, given in their usual monotherapy regimens in patients whose intraocular pressure (IOP) was not controlled on timolol twice daily alone.
Design
Parallel, randomized, double-masked, and active-controlled study.
Participants
Enrolled were 253 patients from 22 sites throughout the United States.
Intervention
After a 3-week run-in of timolol (TIMOPTIC; Merck & Co., Inc., Whitehouse Station, NJ) twice daily, eligible patients received either the combination (COSOPT; Merck & Co., Inc., Whitehouse Station, NJ) twice daily (plus placebo to ensure masking), timolol twice daily (plus placebo to ensure masking), or dorzolamide (TRUSOPT; Merck & Co. Inc., Whitehouse Station, NJ) three times daily for 3 months.
Main outcome measures
Intraocular pressure taken at hours 0 (trough) and 2 (peak) after week 2 and months 1, 2, and 3 was compared to baseline within each treatment group and between the combination and each component group. The safety profile of the combination was compared to each component.
Results
The combination was numerically superior at all study timepoints and was statistically superior at all timepoints except for month 2, hour 0 for timolol, and month 2, hour 2 for dorzolamide. The safety profile of the combination reflected those of its two components. The number of patients reporting ocular or local adverse experiences was greater for the combination (45%) and dorzolamide (45%) than for timolol (27%), with burning and/or stinging eye being the most frequently reported.
Conclusion
The dorzolamide-timolol combination provides additional IOP lowering compared to either of its individual components and generally is well-tolerated.
Manuscript no. 97780.
1Department of Clinical Research, Merck Research Laboratories, West Point, Pennsylvania, USA
3Department of Statistics, Merck Research Laboratories, West Point, Pennsylvania, USA
Reprint requests to Coleen M. Clineschmidt, BA, Merck Research Laboratories (BL1-3), West Point, PA 19486 USA
☆ Supported by Merck & Co., Inc, Whitehouse Station, New Jersey.
1 Ms. Clineschmidt, Dr. Adamsons, Dr. Snyder, and Dr. Reines are employees of Merck & Co., Inc., the manufacturer of the dorzolamide-timolol combination. The other authors have no proprietary interest in the dorzolamide-timolol combination or in Merck.
∗ Members of the Dorzolamide-Timolol Combination Study Group are listed in the Appendix at the end of this article.
ABSTRACT