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A randomized trial in patients inadequately controlled with timolol alone comparing the dorzolamide-timolol combination to monotherapy with timolol or dorzolamide.
Ophthalmology. 1999 Dec; 106(12 Suppl):17-24.O

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.

Authors+Show Affiliations

Department of Clinical Research, Merck Research Laboratories, West Point, Pennsylvania 19486, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Duplicate Publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10598693

Citation

Clineschmidt, C M., et al. "A Randomized Trial in Patients Inadequately Controlled With Timolol Alone Comparing the Dorzolamide-timolol Combination to Monotherapy With Timolol or Dorzolamide." Ophthalmology, vol. 106, no. 12 Suppl, 1999, pp. 17-24.
Clineschmidt CM, Williams RD, Snyder E, et al. A randomized trial in patients inadequately controlled with timolol alone comparing the dorzolamide-timolol combination to monotherapy with timolol or dorzolamide. Ophthalmology. 1999;106(12 Suppl):17-24.
Clineschmidt, C. M., Williams, R. D., Snyder, E., & Adamsons, I. A. (1999). A randomized trial in patients inadequately controlled with timolol alone comparing the dorzolamide-timolol combination to monotherapy with timolol or dorzolamide. Ophthalmology, 106(12 Suppl), 17-24.
Clineschmidt CM, et al. A Randomized Trial in Patients Inadequately Controlled With Timolol Alone Comparing the Dorzolamide-timolol Combination to Monotherapy With Timolol or Dorzolamide. Ophthalmology. 1999;106(12 Suppl):17-24. PubMed PMID: 10598693.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial in patients inadequately controlled with timolol alone comparing the dorzolamide-timolol combination to monotherapy with timolol or dorzolamide. AU - Clineschmidt,C M, AU - Williams,R D, AU - Snyder,E, AU - Adamsons,I A, PY - 1999/12/22/pubmed PY - 1999/12/22/medline PY - 1999/12/22/entrez SP - 17 EP - 24 JF - Ophthalmology JO - Ophthalmology VL - 106 IS - 12 Suppl N2 - 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. SN - 0161-6420 UR - https://www.unboundmedicine.com/medline/citation/10598693/A_randomized_trial_in_patients_inadequately_controlled_with_timolol_alone_comparing_the_dorzolamide_timolol_combination_to_monotherapy_with_timolol_or_dorzolamide_ DB - PRIME DP - Unbound Medicine ER -