Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

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

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

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. Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy. Best corrected visual acuity of -0.6 logMAR or better in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Treatment with BAK preserved artificial tears within 30 days of Visit 1. Known or suspected Sjogren's disease. Uncontrolled IOP. History or evidence of infectious or inflammatory ocular conditions. Progressive retinal or optic nerve disease. Ocular laser surgery within 3 months of Visit 1. Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1. Current use of punctal plugs or punctal cautery. Use of systemic medications that has not been stable for 30 days prior to Visit 1. Use of contact lens within 30 days of 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: Double


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: TRAVATAN Z®;|
| 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: XALATAN®;|

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 (TFBUT) | 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. | Day 0, 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. | Day 0, Day 84 | 

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