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

Phase 4

Completed

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

• Registration Number: NCT00798759
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this 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: 2008-11-24
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Study Start: 2008-12
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2012-03-30
• Results First Submitted QC: 2012-03-30
• Results First Posted: 2012-04-23
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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 & 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 at night for 12 weeks
Latanoprost	Latanoprost ophthalmic solution 0.005% (XALATAN®)	One drop self-administered in the study eye(s) once daily at night for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)	Day 0, Day 84	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score	Day 0, Day 84	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.