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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.
 
ClinicalTrials.gov Identifier: NCT00061516
Recruitment Status : Completed
First Posted : May 30, 2003
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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

Study Design
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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

Arms and Interventions
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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%


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

Eligibility Criteria
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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.


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Ages Eligible for Study:   1 Week to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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Responsible Party: Alcon Research
ClinicalTrials.gov 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:
Glaucoma
Ocular Hypertension
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Eye Diseases
Brinzolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action