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: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension; Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)

• Registration Number: NCT00314171
• 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: 2005-10
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-12
• Study First Posted: 2006-04-13
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2012-03
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

Inclusion Criteria

• 18 years or older
• Diagnosis of open-angle glaucoma or ocular hypertension
• 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
Brinzolamide + Timolol	Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension	-
Dorzolamide + Timolol	Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)	-

Primary Outcome Measures

Name	Time	Method
Mean IOP

Secondary Outcome Measures

Name	Time	Method
Percent patients with IOP < 18 mmHg