Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

Phase 3

Withdrawn

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: DuoTrav APS; Drug: DuoTrav

• Registration Number: NCT00862472
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion Criteria

• VA not worse than 0.60
• additional clinically relevant ocular or systemic conditions may be excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DuoTrav APS	DuoTrav APS	DuoTrav APS QD AM
DuoTrav	DuoTrav	DuoTrav QD AM

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP)	3 Months