Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

Study Overview
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Brief Summary
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The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Official Title
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An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
* Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost<br>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®)<br>* 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.<br>* Other names: TRAVATAN Z®;|
| Active Comparator: Latanoprost<br>One drop self-administered in the study eye(s) once daily for 90 days | Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)<br>* 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.<br>* Other names: XALATAN®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | Day 0, Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 tht total number of patients analyzed. | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-angle glaucoma, ocular hypertension