Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: BETAXON (levobetaxolol HCl) (Drug); AZOPT (brinzolamide) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research
Summary
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.
Clinical Details
Official title: Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: N/A.
Maximum age: 5 Years.
Gender(s): Both.
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
Locations and Contacts
Alcon Call Center, Fort Worth, Texas, United States
Additional Information
Starting date: January 2003
Last updated: August 4, 2008
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