The efficacy and safety of dorzolamide as adjunctive therapy to timolol maleate gellan solution in patients with elevated intraocular pressure

Ingrid Adamsons, Coleen Clineschmidt, Adam Polis, Jennifer Taylor, Arthur Shedden, Robert Laibovitz, Stuart Ball, Todd L. Beyer, Howard Barnebey, Reay H. Brown, Thomas Y. Chandler, Kevin J. Chismire, John S. Cohen, Jack Daubert, Mark A. DiPillo, Monte S. Dirks, Stacey Embry, Richard Evans, Ronald Goldman, Ronald L. GrossAlden James, David W. Karp, Melvyn M. Koby, Jay P. Kelman, Harry Kolodner, John Kwedar, Richard A. Lewis, Douglas Litchfield, Gregory Louis, James Mattax, Thomas Mundorf, William Murrah, Charles S. Ostrov, Leonard M. Parver, Michael Rotberg, C. Eric Shrader, Mary C. Schanzer, Gerald Striph, Shelly Temperly, Mark R. Tucker, Jerald B. Turner, Robert J. Vergnani, Robert D. Williams

Research output: Contribution to journalArticlepeer-review

22 Scopus citations

Abstract

Purpose: Two parallel, randomized, double-masked, placebo-controlled studies were conducted to assess the efficacy and safety of 2% dorzolamide hydrochloride as adjunctive therapy to 0.5% timolol maleate ophthalmic gellan (gel-forming) solution in patients with elevated intraocular pressure (IOP) that was inadequately controlled with 0.5% timolol maleate gellan solution alone. Methods: Both studies began with an open-label 2-week run-in period on 0.5% timolol maleate gellan solution once a day. The only variation in method between the two studies was the dosage of 2% dorzolamide. In one study, 202 patients received 0.5% timolol maleate gellan solution once daily plus either 2% dorzolamide or placebo three times daily. In the other study, 181 patients received 0.5% timolol maleate gellan solution once daily plus either 2% dorzolamide or placebo twice daily. Results: After 85 days, additional mean percent reductions in IOP from baseline at morning trough for the groups receiving 2% dorzolamide three times daily and placebo three times daily were 12.5% and 8.4%, respectively. Mean percent reductions for the groups receiving 2% dorzolamide twice daily and placebo twice daily were 13.1% and 6.5%, respectively. Burning and/or stinging on instillation were the only adverse experiences that affected significantly more of the patients receiving 2% dorzolamide twice or three times daily than those receiving placebo. Conclusion: When administered concomitantly with 0.5% timolol maleate gellan solution, 2% dorzolamide three times daily or twice daily produced a statistically significant reduction in IOP at morning trough and peak and was generally well tolerated.

Original languageEnglish (US)
Pages (from-to)253-260
Number of pages8
JournalJournal of glaucoma
Volume7
Issue number4
DOIs
StatePublished - Aug 1998
Externally publishedYes

Keywords

  • Dorzolamide hydrochloride
  • Timolol maleate gellan solution

ASJC Scopus subject areas

  • Ophthalmology

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