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

Alcon Research236 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

236

Conditions

Open-angle Glaucoma Ocular Hypertension

Interventions

Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)DRUG

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.

Latanoprost ophthalmic solution 0.005% (XALATAN®)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Day 0, Day 84

Secondary Outcomes

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.

Time frame: Day 0, Day 84

Data from ClinicalTrials.gov

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