Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination

• Registration Number: NCT01336569
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-18
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-05
• Results First Submitted: 2013-05-17
• Results First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Results First Posted: 2013-07-08
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
• Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
• On a stable medication regimen for IOP reduction one week prior to the screening visit;
• Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
• Sign informed consent;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
• Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
• Infection in either eye;
• Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
• Risk for visual field or visual acuity worsening, in the opinion of the investigator;
• Women of childbearing potential;
• Pregnant or lactating women;
• Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
• Participation in another clinical study within 30 days before the screening visit;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DuoTrav	Travoprost 0.004%/timolol maleate 0.5% fixed combination	Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)	Baseline, up to 6 weeks	As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States