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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DuoTrav

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

Group Type EXPERIMENTAL

Travoprost 0.004%/timolol maleate 0.5% fixed combination

Intervention Type DRUG

Interventions

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Travoprost 0.004%/timolol maleate 0.5% fixed combination

Intervention Type DRUG

Other Intervention Names

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DuoTrav

Eligibility Criteria

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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;

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No