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A Double-Masked, Randomized, 1-Year Study Comparing the Corneal Effects of Dorzolamide, Timolol, and Betaxolol
Jonathan H. Lass, MD;
Samer A. Khosrof, MD;
Jean K. Laurence, BS;
Barry Horwitz, MD;
Kalyan Ghosh, PhD;
Ingrid Adamsons, MD, MPH;
for the Dorzolamide Corneal Effects Study Group
Arch Ophthalmol. 1998;116:1003-1010.
Objective To compare the long-term effects of dorzolamide hydrochloride (Trusopt, Merck and Co Inc, Whitehouse Station, NJ), timolol maleate, and betaxolol hydrochloride on corneal endothelial cell density and corneal thickness.
Methods This 1-year multicenter study was conducted in 298 patients with ocular hypertension or open-angle glaucoma who had a baseline central corneal endothelial cell density greater than 1500 cells/mm2 and central corneal thickness less than 0.68 mm in each eye. Patients were randomized to 0.5% betaxolol twice daily, 0.5% timolol twice daily, or 2.0% dorzolamide 3 times daily. Specular microscopy and ultrasonic pachymetry of the central cornea was performed at baseline and 6 and 12 months following institution of therapy. Endothelial cell densities were determined by a single masked observer.
Results The mean percent changes from baseline for both outcome measures were similar in all 3 treatment groups at both 6 and 12 months. After 1 year of treatment, the mean percent loss in endothelial cell density from baseline was 3.6%, 4.5%, and 4.2% for the dorzolamide, timolol, and betaxolol groups, respectively. The mean percent change from baseline for corneal thickness was 0.47%,-0.25%, and 0.39% for the dorzolamide, timolol, and betaxolol groups, respectively.
Conclusions Dorzolamide is equivalent to timolol and betaxolol in terms of the change in central endothelial cell density and thickness after 1 year of therapy. All 3 treatments exhibit good long-term corneal tolerability in patients with normal corneas at baseline.
From the Department of Ophthalmology, Case Western Reserve University and University Hospitals of Cleveland, Ohio (Drs Lass and Khosrof); Merck Research Laboratories, West Point, Pa (Ms Laurence and Drs Ghosh and Adamsons); and Clinical Bioresearch Associates, Houston, Tex (Dr Horwitz). Dr Khosrof is now at Massachusetts Eye and Ear Infirmary and Boston Children's Hospital, Boston. Drs Ghosh and Adamsons and Ms Lawrence were employees of Merck and Co Inc, the manufacturer of dorzolamide, at the time this study was conducted. The other authors have no proprietary interest in dorzolamide or Merck and Co Inc.
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