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Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

NCT ID: NCT00637130

Last Updated: 2012-12-06

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

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

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Conditions

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Travoprost 0.0008%

Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Group Type EXPERIMENTAL

Travoprost ophthalmic solution, 0.0008%

Intervention Type DRUG

Travoprost 0.001%

Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Group Type EXPERIMENTAL

Travoprost ophthalmic solution, 0.001%

Intervention Type DRUG

Travoprost 0.0012%

Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Group Type EXPERIMENTAL

Travoprost ophthalmic solution, 0.0012%

Intervention Type DRUG

TRAVATAN + Vehicle

TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks

Group Type ACTIVE_COMPARATOR

TRAVATAN

Intervention Type DRUG

Vehicle

Intervention Type OTHER

Vehicle

Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

Interventions

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Travoprost ophthalmic solution, 0.0008%

Intervention Type DRUG

Travoprost ophthalmic solution, 0.001%

Intervention Type DRUG

Travoprost ophthalmic solution, 0.0012%

Intervention Type DRUG

TRAVATAN

Intervention Type DRUG

Vehicle

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension

Exclusion Criteria

* Age related
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

Locations

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Contact Alcon Call Center at 1-888-451-3937

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-06-11

Identifier Type: -

Identifier Source: org_study_id