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Abstract #13094 Published in IGR 7-3
A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years
Ott EZ; Mills MD; Arango S; Getson AJ; Assaid CA; Adamsons IAArchives of Ophthalmology 2005; 123: 1177-1186
OBJECTIVE: To evaluate dorzolamide hydrochloride in patients younger than 6 years who have an elevated intraocular pressure or glaucoma. DESIGN: A 3-month, controlled, randomized, double-masked, multicenter, clinical trial. Patients were randomized to 2% dorzolamide 3 times daily or timolol maleate gel-forming solution (0.25% for patients < 2 years and 0.5% for patients ≥ 2 but < 6 years) once daily plus placebo twice daily. If the intraocular pressure was not controlled through monotherapy, younger patients received concomitant dorzolamide 3 times daily and 0.25% timolol gel-forming solution once daily and older patients received a fixed combination of 2% dorzolamide and 0.5% timolol twice daily. The primary safety variable was the proportion of patients who discontinued therapy for a drug-related adverse experience. Intraocular pressure reduction was a secondary measure. RESULTS: One younger patient (1.8%) of 56 randomized to dorzolamide discontinued concomitant therapy because of bradycardia. Two older patients (3.0%) of 66 discontinued dorzolamide because of ocular adverse experiences. The most frequent ocular adverse experiences were discharge and ocular hyperemia (younger cohort) and ocular hyperemia and burning/stinging (older cohort). At week 12, the mean change in intraocular pressure for dorzolamide was statistically significant from baseline (-7.3 mmHg [-20.6%] and -7.1 mmHg [-23.3%]) in the younger and older cohorts, respectively; P < .001 for both. CONCLUSION: Dorzolamide was generally well tolerated and demonstrated efficacy for up to 3 months in patients younger than 6 years.
Dr. E.Z. Ott, Department of Clinical Research, Merck Research Laboratories Inc., West Point, PA 19486, USA
Classification:
11.5.2 Topical (Part of: 11 Medical treatment > 11.5 Carbonic anhydrase inhibitors)
