A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Glaucoma, Open-angle; Ocular Hypertension
• Interventions: Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution; Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution

• Registration Number: NCT00311389
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2006-04-04
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-11
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

• As specified in protocol

Exclusion Criteria

• As specified in protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost/Timolol	Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution	1 drop in the affected eye(s) once daily in the morning for 12 months
Latanoprost/Timolol	Latanoprost 0.005%/Timolol 0.005% ophthalmic solution	1 drop in the affected eye(s) once daily in the morning for 12 months

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP)	12 months

Trial Locations

Locations (1)

European Facilitiies; 🇧🇪 Puurs, Belgium