Effects of Travatan Z and Xalatan on Ocular Surface Health

Study Overview
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Brief Summary
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The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.

Official Title
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Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and Xalatan®

Conditions
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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 of age or older. Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye). Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1. IOP controllable and stable on the study medication alone (both eyes). Believed to have ocular surface disease (OSD). Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye. Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs. Current use of punctual plugs. Women of childbearing potential not using reliable means of birth control. Women who are pregnant or lactating. Suspected or diagnosed with Sjogrens's syndrome. Current use of any brand of artificial tears containing BAK. Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study. Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1. Current use of contact lenses within 30 days of Visit 1. Participation in any other investigational study within 30 days prior to Visit 1. 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost<br>One drop self-administered in the study eye(s) once daily at night for 12 weeks | 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 12 weeks (84 days). Referred to as travoprost.<br>* Other names: travoprost;|
| Active Comparator: Latanoprost<br>One drop self-administered in the study eye(s) once daily at night for 12 weeks | 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 12 weeks (84 days). Referred to as latanoprost.<br>* Other names: latanoprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT) | Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time. | 12 weeks (Day 84) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change at 12 Weeks (Day 84) 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. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health. | 12 weeks (Day 84) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular surface health, TFBUT, Glaucoma, OSDI, Ocular hypertension, Corneal staining