May 2004
Volume 45, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2004
A randomized trial assessing the tolerability and efficacy of Dorzolamide in pediatric patients less than 6 years of age with elevated intraocular pressure or glaucoma
Author Affiliations & Notes
  • M.D. Mills
    Ophthalmology, Children's Hospital of Philadelphia, Philadelphia, PA
    Scheie Eye Institute, University of Pennsylvania Medical School, Philadelphia, PA
  • E.Z. Ott
    Merck Research Laboratories, West Point, PA
  • S. Arango
    Clinica Oftalmologia Sandiego, Medellin, Colombia
  • A.J. Getson
    Merck Research Laboratories, West Point, PA
  • C.A. Assaid
    Merck Research Laboratories, West Point, PA
  • I.A. Adamsons
    Merck Research Laboratories, West Point, PA
  • Pediatric Dorzolamide Study Group
    Ophthalmology, Children's Hospital of Philadelphia, Philadelphia, PA
  • Footnotes
    Commercial Relationships  M.D. Mills, Merck & Co., Inc. F; E.Z. Ott, Merck & Co., Inc. E; S. Arango, Merck & Co., Inc. F; A.J. Getson, Merck & Co., Inc. E; C.A. Assaid, Merck & Co., Inc. E; I.A. Adamsons, Merck & Co., Inc. E.
  • Footnotes
    Support  Merck & Co., Inc.
Investigative Ophthalmology & Visual Science May 2004, Vol.45, 3531. doi:
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      M.D. Mills, E.Z. Ott, S. Arango, A.J. Getson, C.A. Assaid, I.A. Adamsons, Pediatric Dorzolamide Study Group; A randomized trial assessing the tolerability and efficacy of Dorzolamide in pediatric patients less than 6 years of age with elevated intraocular pressure or glaucoma . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3531.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Abstract: : Purpose: To evaluate the safety and efficacy of dorzolamide 2% in patients less than 6 years of age with elevated intraocular pressure (IOP) or glaucoma. Methods: A total of 184 patients less than 6 years of age, with elevated IOP or glaucoma, were enrolled in the double masked randomized multicenter clinical trial. After completing a washout of any ocular hypotensive medications, patients were randomized to receive either dorzolamide 2% three times daily or timolol maleate gel–forming solution (0.25% for patients <2 years of age and 0.5% for patients > 2 years but < 6 years of age) once daily plus placebo twice daily. If IOP was not adequately controlled on monotherapy, then patients in the younger cohort recieved concomitant therapy of dorzolamide three times daily and timolol gel–forming solution 0.25% once daily; and patients in the older cohort received the dorzolamide 2%/timolol 0.5% fixed combination twice daily. The primary outcome parameter was the proportion of patients who discontinued therapy due to a drug–related adverse experience during the 3–month trial. A secondary measure of intraocular pressure (IOP) was measured. Results: In the <2 years age cohort, one patient (1.8%) discontinued concomitant dorzolamide and timolol therapy due to bradycardia (95% confidence interval (0.1%, 9.6%) for the true proportion of such discontinuations). In the >2 years but <6 years age cohort, 2 patients (3.0%) discontinued dorzolamide due to ocular adverse experiences (95% confidence interval of (0.4%, 10.5%) for the true proportion of such discontinuations). In both age cohorts, there were statistically significant decreases in IOP from baseline. At week 12 the mean change in IOP for dorzolamide was –7.3 (–20.6%) mmHg and –7.1 (–23.3%) mmHg in the younger and older cohorts, respectively. Conclusions: Dorzolamide 2% tid taken for up to 3 months was generally well–tolerated and demonstrated efficacy in pediatric patients <6 years of age with elevated IOP or glaucoma.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • pharmacology • ocular irritancy/toxicity testing 
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