Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

Phase 3

Completed

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

• Registration Number: NCT00761319
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-29
• Study Start: 2008-10
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2012-03-30
• Results First Submitted QC: 2012-03-30
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-20
• Results First Posted: 2012-04-23
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 705

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Travoprost	Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)	One drop self-administered in the study eye(s) once daily for 90 days
Latanoprost	Latanoprost ophthalmic solution 0.005% (XALATAN®)	One drop self-administered in the study eye(s) once daily for 90 days

Primary Outcome Measures

Name	Time	Method
Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score	Day 0, Day 90	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Corneal Fluorescein Staining Score = 0	Day 90	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.