Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: BETOPTIC S (betaxolol HCl); Drug: Timolol Gel-forming Solution (TGFS)

• Registration Number: NCT00061542
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution 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: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-08
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Betaxolol	BETOPTIC S (betaxolol HCl)	Two doses daily for 12 weeks
TGFS 0.25%	Timolol Gel-forming Solution (TGFS)	Two doses daily for 12 weeks
TGFS 0.5%	Timolol Gel-forming Solution (TGFS)	Two doses daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in IOP	Up to Week 12

Trial Locations

Locations (1)

Alcon Call Center; 🇺🇸 Fort Worth, Texas, United States