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

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

The purpose of this 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): 236
• Phase: Phase 4

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.
• 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.

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 at night for 12 weeks	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 12 weeks (84 days). Referred to as travoprost.; Other Names: TRAVATAN Z®
Active Comparator: Latanoprost; One drop self-administered in the study eye(s) once daily at night for 12 weeks	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 12 weeks (84 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 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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): June 1, 2012
• Last Update Submitted That Met QC Criteria: May 25, 2012
• Last Verified: May 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-08-050