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Ocular Surface Effects of Prostaglandin Analogues (PGAs)
This study is not yet open for participant recruitment.
Verified by Alcon Research, July 2008
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00708422
  Purpose

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®.


Condition Intervention Phase
Glaucoma
Drug: Travoprost eye drop
Drug: Latanoprost
Phase IV

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost Tetrahydrozoline Tetrahydrozoline hydrochloride Travoprost
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Measuring TBUT [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in OSDI score [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: July 2008
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Travoprost BAK-free
Drug: Travoprost eye drop
Ophthalmic solution
2: Active Comparator
Latanoprost
Drug: Latanoprost

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708422

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

Locations
United States, Texas
Call Alcon Call Center for Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon ( Mark Jasek )
Study ID Numbers: SMA-08-07
Study First Received: June 30, 2008
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00708422  
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma
TBUT
IOP

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Tetrahydrozoline
Latanoprost
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009