The objective of this study is to examine the affect on tear film break up time (TBUT) of changing patients on Xalatan® therapy to TRAVATAN Z®.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Travoprost eye drop
  • Ophthalmic solution
• Drug: Latanoprost

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Travoprost BAK-free
• Active Comparator: 2
  • Latanoprost

Primary Measures

• Measuring TBUT
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Change in OSDI score
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Diagnosis of primary open angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
• 2. Patients who have been on a BAK containing IOP-lowering medication for a minimum of one year with at least the last 6 months on Xalatan® monotherapy and are believed to have OSD.
• 3. The intraocular pressure in both eyes should be able to be controlled and stable on the study medication alone.
• 4. Tear Break-up Time (TBUT) of ≤ 6 seconds
• 5. Must be 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.

Exclusion Criteria:

• 1. Current use or use within the last 3 months of Restasis®, topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
• 2. Current use of punctual plugs.
• 3. Women of childbearing potential not using reliable means of birth control.
• 4. Women who are pregnant or lactating.
• 5. Suspected or diagnosed with Sjogrens's syndrome
• 6. Current use of any brand of artificial tears containing benzalkonium chloride (BAK).
• 7. Use of any systemic medications on a chronic basis that have not been 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.
• 8. Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
• 9. Current use of contact lenses within 30 days of Visit 1.
• 10. Presence of other primary or secondary glaucoma not listed in inclusion criterion 1.
• 11. Any clinically significant, serious, or severe medical or psychiatric condition.
• 12. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
• 13. Participation in any other investigational study within 30 days prior to Visit 1.
• 14. Known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alcon Research

Overall Clinical Trial Officials and Contacts

Overall Contact: Alcon Call Center 1-888-451-3937 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00708422

Study ID Number: SMA-08-07

ClinicalTrials.gov Identifier: NCT00708422

Health Authority: United States: Food and Drug Administration