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Travoprost 3-Month Safety and Efficacy Study

NCT ID: NCT01453855

Last Updated: 2013-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1099 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

Detailed Description

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This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Conditions

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Open-Angle Glaucoma Ocular Hypertension

Keywords

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Travoprost 0.003%

Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months

Group Type EXPERIMENTAL

Travoprost ophthalmic solution, 0.003%

Intervention Type DRUG

TRAVATAN

Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months

Group Type ACTIVE_COMPARATOR

Travoprost ophthalmic solution, 0.004%

Intervention Type DRUG

Interventions

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Travoprost ophthalmic solution, 0.003%

Intervention Type DRUG

Travoprost ophthalmic solution, 0.004%

Intervention Type DRUG

Other Intervention Names

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TRAVATAN®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
* Qualifying intraocular pressure at both eligibility visits.
* Understand and sign an informed consent form.

Exclusion Criteria

* Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
* Severe central visual field loss in either eye.
* Chronic, recurrent or severe inflammatory eye disease.
* Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
* Any abnormality preventing reliable applanation tonometry.
* Hypersensitivity to prostaglandin analogs or to any component of the study medications.
* Therapy with another investigational agent within 30 days prior to the Screening Visit.
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 A Landry, PhD

Role: STUDY_DIRECTOR

Alcon Research

Countries

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United States

Other Identifiers

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2011-004587-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C-11-034

Identifier Type: -

Identifier Source: org_study_id