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Effects of Travatan Z and Xalatan on Ocular Surface Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708422
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : April 23, 2012
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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 Xalatan once daily for 12 weeks.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and Xalatan®
Study Start Date : July 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Travoprost
One drop self-administered in the study eye(s) once daily at night for 12 weeks
Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.
Other Names:
  • TRAVATAN Z®
  • travoprost

Active Comparator: Latanoprost
One drop self-administered in the study eye(s) once daily at night for 12 weeks
Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.
Other Names:
  • XALATAN®
  • latanoprost




Primary Outcome Measures :
  1. Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT) [ Time Frame: 12 weeks (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 :
  1. Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score [ Time Frame: 12 weeks (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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708422


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Judy Vittitoe, RN, MPH Alcon Research
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00708422    
Other Study ID Numbers: SMA-08-07
First Posted: July 2, 2008    Key Record Dates
Results First Posted: April 23, 2012
Last Update Posted: April 23, 2012
Last Verified: March 2012
Keywords provided by Alcon Research:
Ocular surface health
OSDI
TFBUT
Glaucoma
Ocular hypertension
Corneal staining
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Travoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents