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

December 4, 2012 updated by: Alcon Research

Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center at 1-888-451-3937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Age related
  • Other protocol-defined exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Travoprost 0.0008%
Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Drug: Travoprost ophthalmic solution, 0.0008%
Experimental: Travoprost 0.001%
Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Drug: Travoprost ophthalmic solution, 0.001%
Experimental: Travoprost 0.0012%
Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Drug: Travoprost ophthalmic solution, 0.0012%
Active Comparator: 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
Other: Vehicle
Drug: TRAVATAN
Placebo Comparator: Vehicle
Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Other: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Intraocular Pressure
Time Frame: Up to 2 weeks
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-06-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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