A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years.

Abstract

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 > or =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.

• Authors: Elyssa Z Ott, Monte D Mills, Santiago Arango, Albert J Getson, Christopher A Assaid, Ingrid A Adamsons
• Journal: Archives of ophthalmology (Chicago, Ill. : 1960) (Arch Ophthalmol) Vol. 123 Issue 9 Pg. 1177-86 (Sep 2005) ISSN: 0003-9950 [Print] United States
• PMID: 16157797 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Ophthalmic Solutions
• Sulfonamides
• Thiophenes
• Timolol
• dorzolamide

Topics

• Antihypertensive Agents (administration & dosage, adverse effects)
• Child, Preschool
• Double-Blind Method
• Female
• Glaucoma (drug therapy, etiology)
• Humans
• Infant
• Intraocular Pressure (drug effects)
• Male
• Ocular Hypertension (drug therapy)
• Ophthalmic Solutions (administration & dosage)
• Prospective Studies
• Safety
• Sulfonamides (administration & dosage, adverse effects)
• Thiophenes (administration & dosage, adverse effects)
• Timolol (administration & dosage, adverse effects)
• Treatment Outcome