Effects of Travatan Z and Xalatan on Ocular Surface Health

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

The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; 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): 231
• 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 of age or older.
• Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
• Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
• IOP controllable and stable on the study medication alone (both eyes).
• Believed to have ocular surface disease (OSD).
• Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
• Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
• Current use of punctual plugs.
• Women of childbearing potential not using reliable means of birth control.
• Women who are pregnant or lactating.
• Suspected or diagnosed with Sjogrens's syndrome.
• Current use of any brand of artificial tears containing BAK.
• Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
• Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
• Current use of contact lenses within 30 days of Visit 1.
• Participation in any other investigational study within 30 days prior to 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: Triple

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: travoprost; 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: latanoprost; 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 (TBUT)	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.	12 weeks (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.	12 weeks (Day 84)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Judy Vittitoe, RN, MPH, Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: July 1, 2008
• First Posted (Estimate): July 2, 2008

Study Record Updates

• Last Update Posted (Estimate): April 23, 2012
• Last Update Submitted That Met QC Criteria: March 30, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Ocular hypertension; Glaucoma; Ocular surface health; OSDI; TFBUT; Corneal staining
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost; Latanoprost
• Other Study ID Numbers: SMA-08-07