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Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

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ClinicalTrials.gov Identifier: NCT00798759
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : April 23, 2012
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open-angle 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 : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and XALATAN®
Study Start Date : December 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009


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 Name: TRAVATAN Z®

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 Name: XALATAN®




Primary Outcome Measures :
  1. Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT) [ Time Frame: Day 0, 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: Day 0, 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.



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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 or older.
  • Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
  • Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
  • Best corrected visual acuity of -0.6 logMAR or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Treatment with BAK preserved artificial tears within 30 days of Visit 1.
  • Known or suspected Sjogren's disease.
  • Uncontrolled IOP.
  • History or evidence of infectious or inflammatory ocular conditions.
  • Progressive retinal or optic nerve disease.
  • Ocular laser surgery within 3 months of Visit 1.
  • Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
  • Current use of punctal plugs or punctal cautery.
  • Use of systemic medications that has not been stable for 30 days prior to Visit 1.
  • Use of contact lens within 30 days of Visit 1.
  • Other protocol-defined exclusion criteria may apply.
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00798759    
Other Study ID Numbers: C-08-050
First Posted: November 26, 2008    Key Record Dates
Results First Posted: April 23, 2012
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Alcon Research:
Open-angle glaucoma
Ocular hypertension
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Travoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents