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

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: AZOPT (brinzolamide); Drug: BETAXON (levobetaxolol HCl)

• Registration Number: NCT00061516
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-05-28
• Study First Submitted QC: 2003-05-29
• Study First Posted: 2003-05-30
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2008-08
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brinzolamide suspension, 1%	AZOPT (brinzolamide)	Dosed twice daily for 12 weeks
Levobetaxolol suspension, 0.5%	BETAXON (levobetaxolol HCl)	Dosed twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline IOP	Up to Week 12