Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Alcon Research78 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glaucoma Ocular Hypertension

Interventions

BETAXON (levobetaxolol HCl)DRUG

levobetaxolol suspension, 0.5%

AZOPT (brinzolamide)DRUG

brinzolamide suspension, 1%

Eligibility

Sex: ALLMin age: 1 WeekMax age: 5 Years

Medical Language ↔ Plain English

INCLUSION: * Children 5 years old and younger * require treatment for glaucoma or ocular hypertension * vision is 20/80 or better * cup-to-disc ratio of 0.8 or less EXCLUSION: * do not have abnormal fixation * IOP greater than 36 mm Hg * significant retinal disease * penetrating keratoplasty * severe ocular pathology * optic atrophy * eye surgery in the past 30 days * cardiovascular abnormalities * hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs

Outcomes

Primary Outcomes

Mean Change from Baseline IOP

Time frame: Up to Week 12

Data from ClinicalTrials.gov

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