Status:
COMPLETED
Effects of Travatan Z and Xalatan on Ocular Surface Health
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Xalata...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00708422
Start Date
July 1 2008
End Date
August 1 2009
Last Update
April 23 2012
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