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Elyssa Z. Ott, BS; Monte D. Mills, MD; Santiago Arango, MD; Albert J. Getson, PhD; Christopher A. Assaid, PhD; Ingrid A. Adamsons, MD, MPH; for the Pediatric Dorzolamide Study Group

Arch Ophthalmol. 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 mm Hg [–20.6%] and –7.1 mm Hg [–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.

Author Affiliations: Departments of Clinical Research (Ms Ott) and Biostatistics (Drs Getson and Assaid), and Clinical Risk Management and Safety Surveillance (Dr Adamsons), Merck Research Laboratories, West Point, Pa; Department of Ophthalmology, Children’s Hospital of Philadelphia, Philadelphia, Pa (Dr Mills); and Clinica Oftalmologia Sandiego, Medellin, Colombia (Dr Arango).