Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health

July 11, 2014 updated by: Alcon Research
The purpose of this study is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

434

Phase

  • Phase 3

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:

  • Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye.
  • Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
  • Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit 1.

  • Women of childbearing potential must meet all of the following conditions at Visit 1:

    • They are not breast-feeding.
    • They have a negative urine pregnancy test at Visit 1.
    • They agree to undertake a urine pregnancy test upon entering and exiting the study.
    • They are not planning to become pregnant during the course of the study.
    • They are currently using, and agree to use adequate birth control methods for the duration of the study.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any abnormality preventing reliable applanation tonometry in the study eye(s).
  • Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
  • Dry eye or keratoconjunctivitis sicca (KCS) which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
  • Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
  • Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
  • Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye.
  • Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1.
  • Use of ocular medications other than XALATAN® within 7 days of Visit 1.
  • Use of corticosteroids within 30 days of Visit 1.
  • Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Participation in an investigational drug or device study within 30 days of entering this study.
  • History or evidence of corneal transplant or transplant variant procedures.
  • Other protocol-specified 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Travoprost APS
Travoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
Drug: Travoprost APS 40 micrograms/ml eye drop solution
non-BAK (benzalkonium chloride) medication
Active Comparator: XALATAN
Latanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
Drug: Latanoprost 50 micrograms/ml eye drop solution
BAK-preserved medication
Other Names:
  • XALATAN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)
Time Frame: Day 90
Day 90

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Theresa Landry, Ph.D., 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

June 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-09-001

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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