A six-week dose-response study of the ocular hypotensive effect of dorzolamide with a one-year extension

E. Strahlman, R. Tipping, R. Vogel, P. Abrantes, A. Alm, P. J. Airaksinen, H. Barnebey, A. Borgeois, J. S. Cohen, J. Collignon-Brach, M. N. Cyrlin, P. Demailly, B. Ehinger, J. L. George, E. Greve, R. L. Gross, E. J. Higginbotham, M. A. Kass, R. A. Laibovitz

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Abstract

PURPOSE: To investigate the efficacy and dose-response relationship of three concentrations (0.2%, 0.7%, and 2.0%) of dorzolamide hydrochloride in lowering elevated intraocular pressure (lOP) in patients during a six-week period and to evaluate the efficacy of 0.7% and 2.0% dorzolamide administered for an additional year. METHODS: This prospective, double-masked, randomized, placebo-controlled, multinational study enrolled 333 adults with open-angle glaucoma or ocular hypertension. During the six-week dose-response phase, patients were randomized to thrice-daily dosing of four treatments: 0.2%, 0.7%, or 2.0% dorzolamide or placebo (vehicle of dorzolamide). During a one-year extension, patients received 0.7% or 2.0% dorzolamide, and, if needed, 0.5% timolol twice daily for elevated IOP. RESULTS: In the dose-response phase, mean percent reduction of IOP (peak) was 16% to 18% for 2.0% and 0.7% dorzolamide and 4% to 7% for the placebo group, for a net reduction of IOP by dorzolamide of 11% to 14%. The 0.2% concentration of dorzolamide was not sufficiently active for further consideration. During the extension, dorzolamide maintained an adequate reduction of lOP in 55% (174 of 316) of patients. Throughout the study, the reduction in IOP was numerically greater for patients receiving 2.0% vs 0.7% dorzolamide. After 12 months of receiving dorzolamide, 20% to 28% of total carbonic anhydrase activity was observed. CONCLUSIONS: Topical dorzolamide used three times daily in concentrations of 0.7% or 2.0% lowered lOP and was generally well tolerated as monotherapy or in combination with 0.5% timolol.

Original languageEnglish
Pages (from-to)183-194
Number of pages12
JournalAmerican journal of ophthalmology
Volume122
Issue number2
DOIs
StatePublished - Jan 1 1996

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    Strahlman, E., Tipping, R., Vogel, R., Abrantes, P., Alm, A., Airaksinen, P. J., Barnebey, H., Borgeois, A., Cohen, J. S., Collignon-Brach, J., Cyrlin, M. N., Demailly, P., Ehinger, B., George, J. L., Greve, E., Gross, R. L., Higginbotham, E. J., Kass, M. A., & Laibovitz, R. A. (1996). A six-week dose-response study of the ocular hypotensive effect of dorzolamide with a one-year extension. American journal of ophthalmology, 122(2), 183-194. https://doi.org/10.1016/S0002-9394(14)72009-4