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Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00928590

Last Updated: 2014-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

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Detailed Description

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Conditions

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Open-angle Glaucoma Ocular Hypertension

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 APS

Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months

Group Type EXPERIMENTAL

Travoprost/Timolol Maleate Fixed Combination solution

Intervention Type DRUG

Interventions

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Travoprost/Timolol Maleate Fixed Combination solution

Intervention Type DRUG

Other Intervention Names

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DuoTrav APS DuoTrav (POLYQUAD-preserved)

Eligibility Criteria

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Inclusion Criteria

* Willing and able to sign an informed consent document.
* Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
* Stable treatment of an IOP-lowering medication.

Exclusion Criteria

* Pregnant, breastfeeding, or not using adequate birth control.
* Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theresa Landry, Ph.D

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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EudraCT Number 2009-013178-42

Identifier Type: -

Identifier Source: secondary_id

C-09-032

Identifier Type: -

Identifier Source: org_study_id

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