Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)

• Study Type: Interventional
• Enrollment (Actual): 705
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (Estimate): September 29, 2008

Study Record Updates

• Last Update Posted (Estimate): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 20, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Open-angle glaucoma; ocular hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost; Latanoprost
• Other Study ID Numbers: C-08-047