Back to resultsTravatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Latanoprost ophthalmic solution 0.005% (XALATAN®)
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility 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 medication other than the study medication for the duration of the study, including artificial tears.
- Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost
Latanoprost
Arm Description
One drop self-administered in the study eye(s) once daily for 90 days
One drop self-administered in the study eye(s) once daily for 90 days
Outcomes
Primary Outcome Measures
Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point 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. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
Secondary Outcome Measures
Percentage of Patients With Corneal Fluorescein Staining Score = 0
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 the total number of patients analyzed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00690794
Brief Title
Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
726 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost
Arm Type
Experimental
Arm Description
One drop self-administered in the study eye(s) once daily for 90 days
Arm Title
Latanoprost
Arm Type
Active Comparator
Arm Description
One drop self-administered in the study eye(s) once daily for 90 days
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Other Intervention Name(s)
TRAVATAN Z®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution 0.005% (XALATAN®)
Other Intervention Name(s)
XALATAN®
Intervention Description
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanprost.
Primary Outcome Measure Information:
Title
Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
Description
The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point 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. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
Time Frame
Baseline, Day 90
Secondary Outcome Measure Information:
Title
Percentage of Patients With Corneal Fluorescein Staining Score = 0
Description
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 the total number of patients analyzed.
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 medication other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (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.
12. IPD Sharing Statement
Learn more about this trial
Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
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