A randomized trial assessing dorzolamide in patients with glaucoma who are younger than 6 years.
OBJECTIVE
To evaluate dorzolamide hydrochloride in patients younger than 6 years who have an elevated intraocular pressure or glaucoma.


METHODS
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.


CONCLUSIONS
Dorzolamide was generally well tolerated and demonstrated efficacy for up to 3 months in patients younger than 6 years.
Ott
Elyssa Z
EZ
Department of Clinical Research, Merck Research Laboratories Inc., West Point, PA 19486, USA.
Mills
Monte D
MD
Arango
Santiago
S
Getson
Albert J
AJ
Assaid
Christopher A
CA
Adamsons
Ingrid A
IA
D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005901:Glaucoma / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007223:Infant; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011446:Prospective Studies; D012449:Safety; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D013449:Sulfonamides; D013876:Thiophenes; D013999:Timolol; C062765:dorzolamide