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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.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00061516
First received: May 28, 2003
Last updated: November 16, 2016
Last verified: August 2008
  Purpose
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 Intervention Phase
Glaucoma
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:

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

Enrollment: 78
Study Start Date: January 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   up to 5 Years   (Child)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00061516     History of Changes
Other Study ID Numbers: C-00-17 
Study First Received: May 28, 2003
Last Updated: November 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Brinzolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 05, 2016