Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
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...
Brief Summary
Official Title: “Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension”
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
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: February 2006
Intervention(s) in this Clinical Trial
- Drug: BETAXON (levobetaxolol HCl)
- Drug: AZOPT (brinzolamide)
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 5 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Alcon Research Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00061516
Study ID Number: C-00-17
ClinicalTrials.gov Identifier: NCT00061516
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00061516
