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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00892762
First received: May 4, 2009
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: Travoprost APS 40 micrograms/ml eye drop solution
Drug: Latanoprost 50 micrograms/ml eye drop solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Enrollment: 434
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: XALATAN®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892762

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry, Ph.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00892762     History of Changes
Other Study ID Numbers: C-09-001
Study First Received: May 4, 2009
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Australia: Human Research Ethics Committee
Lithuania: Bioethics Committee
Latvia: Institutional Review Board
Singapore: Institutional Review Board
Italy: Ethics Committee
Belgium: Institutional Review Board
Brazil: Ethics Committee
Hungary: Institutional Ethics Committee
Sweden: Institutional Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
Open Angle Glaucoma
Ocular hypertension
OAG
OH

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Latanoprost
Travoprost
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 26, 2014