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

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: May 28, 2003
Last updated: August 4, 2008
Last verified: August 2008

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.

Condition Intervention Phase
Ocular Hypertension
Drug: BETAXON (levobetaxolol HCl)
Drug: AZOPT (brinzolamide)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Study Start Date: January 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00061516

United States, Texas
Alcon Call Center
Fort Worth, Texas, United States
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided Identifier: NCT00061516     History of Changes
Other Study ID Numbers: C-00-17
Study First Received: May 28, 2003
Last Updated: August 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Ocular Hypertension

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on April 22, 2014