A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Timolol 5 mg/ml eye drops, solution; Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension; Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension

• Registration Number: NCT00314158
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-12
• Study First Posted: 2006-04-13
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2012-03
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 523

Inclusion Criteria

• 18 years of age or older
• Diagnosis of open-angle glaucoma
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria

• Under 18
• Pregnant
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol	Timolol 5 mg/ml eye drops, solution	-
Brinzolamide +Timolol	Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension	-
Brinzolamide	Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension	-

Primary Outcome Measures

Name	Time	Method
Mean intra-ocular pressure (IOP)

Trial Locations

Locations (1)

United States Investigative Sites; 🇺🇸 Fort Worth, Texas, United States