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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00061516
• Collaborator: (none)
• Enrollment: 78
• Arms: 2
• Duration (Months): 37

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jan 1, 2003
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Arms and Interventions

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

Primary Outcome Measures

1. Mean Change from Baseline IOP [Up to Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Week to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00061516
• Other Study ID Numbers: C-00-17
• First Posted: May 30, 2003
• Last Update Posted: Nov 18, 2016
• Last Verified: Aug 1, 2008

• Keywords provided by Alcon Research: Glaucoma; Ocular Hypertension
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Brinzolamide

Study Results

No Results Posted as of Nov 18, 2016