A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension

Phase 3

Completed

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

• Registration Number: NCT00465803
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-23
• Study First Submitted QC: 2007-04-24
• Study First Posted: 2007-04-25
• Primary Completion: 2009-01
• Status Verified: 2012-05
• Disposition First Submitted: 2014-07-22
• Disposition First Submitted QC: 2014-07-22
• Last Update Submitted: 2014-07-22
• Disposition First Posted: 2014-07-24
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Adult patients with open-angle glaucoma or ocular hypertension;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Visual acuity worse than 0.60;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DuoTrav	Travoprost 0.004%/timolol 0.5% ophthalmic solution	One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid
Travatan/Timolol	Timolol maleate ophthalmic solution, 0.5%	One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.
Travatan/Timolol	Travoprost ophthalmic solution, 0.004%	One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.

Primary Outcome Measures

Name	Time	Method
Patient compliance	12 months	Patient compliance will be measured with a dosing aid that records time and date of study drug administration

Trial Locations

Locations (1)

Seattle; 🇺🇸 Seattle, Washington, United States