Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00061516
Recruitment Status : Completed
First Posted : May 30, 2003
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Alcon Research

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: BETAXON (levobetaxolol HCl) Drug: AZOPT (brinzolamide) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Brinzolamide suspension, 1%
Dosed twice daily for 12 weeks
Drug: AZOPT (brinzolamide)
brinzolamide suspension, 1%

Experimental: Levobetaxolol suspension, 0.5%
Dosed twice daily for 12 weeks
Drug: BETAXON (levobetaxolol HCl)
levobetaxolol suspension, 0.5%

Primary Outcome Measures :
  1. Mean Change from Baseline IOP [ Time Frame: Up to Week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Week to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Publications of Results:
Layout table for additonal information
Responsible Party: Alcon Research Identifier: NCT00061516    
Other Study ID Numbers: C-00-17
First Posted: May 30, 2003    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: August 2008
Keywords provided by Alcon Research:
Ocular Hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action