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

Phase 3

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav); Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt); Other: Timolol Vehicle

• Registration Number: NCT00333125
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the intraocular pressure (IOP)-lowering efficacy and safety of two combination products in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-02
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2012-05
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

• 18 or older.
• Diagnosis of glaucoma or ocular hypertension.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost/Timolol	Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)	-
Dorzolamide/Timolol	Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)	-
Travoprost/Timolol	Timolol Vehicle	-

Primary Outcome Measures

Name	Time	Method
Mean Intra-Ocular Pressure (IOP)	6 weeks