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

Phase 3

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost APS 40 micrograms/ml eye drop solution; Drug: Latanoprost 50 micrograms/ml eye drop solution

• Registration Number: NCT00892762
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Study Start: 2009-06
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-11
• Disposition First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Disposition First Posted: 2014-07-15
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost APS	Travoprost APS 40 micrograms/ml eye drop solution	Travoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
XALATAN	Latanoprost 50 micrograms/ml eye drop solution	Latanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days

Primary Outcome Measures

Name	Time	Method
Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)	Day 90