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Completed

NCT Number: NCT00798759

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

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

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)

Drug

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®

Latanoprost ophthalmic solution 0.005% (XALATAN®)

Drug

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®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and XALATAN®

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 26, 2008
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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