Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

Alcon Research705 enrolled

Overview

The purpose of the 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

705

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 90 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 90 days. Referred to as latanoprost.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Day 0, Day 90

Secondary Outcomes

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.

Time frame: Day 90

Data from ClinicalTrials.gov

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