Overview

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

Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Brinzolamide
Criteria
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