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Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761319
First Posted: September 29, 2008
Last Update Posted: April 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Condition Intervention Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score [ Time Frame: Day 0, Day 90 ]
    The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.


Secondary Outcome Measures:
  • Percentage of Patients With Corneal Fluorescein Staining Score = 0 [ Time Frame: Day 90 ]
    The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.


Enrollment: 705
Study Start Date: October 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost
One drop self-administered in the study eye(s) once daily for 90 days
Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.
Other Name: TRAVATAN Z®
Active Comparator: Latanoprost
One drop self-administered in the study eye(s) once daily for 90 days
Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanoprost.
Other Name: XALATAN®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older.
  • Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
  • Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
  • Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
  • Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
  • Best corrected visual acuity of -0.6 logMAR or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
  • Use of contact lenses within 30 days of Visit 1.
  • Use of contact lenses during the study.
  • Participation in an investigational drug or device study within 30 days of entering this study.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00761319     History of Changes
Other Study ID Numbers: C-08-047
First Submitted: September 25, 2008
First Posted: September 29, 2008
Results First Submitted: March 30, 2012
Results First Posted: April 23, 2012
Last Update Posted: April 26, 2012
Last Verified: April 2012

Keywords provided by Alcon Research:
Open-angle glaucoma
ocular hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Travoprost
Antihypertensive Agents