Effects of Travatan Z and Xalatan on Ocular Surface Health

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost

Criteria

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.