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OpenTrials
Completed

NCT Number: NCT00527592

A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary 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 of age or older.
  • Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
  • Best corrected visual acuity of 20/200 Snellen or better in each eye.
  • Intraocular pressure within protocol-specified range.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any abnormality preventing reliable applanation tonometry in the study eye(s).
  • Any eye conditions or procedures as specified in protocol.
  • Progressive retinal or optic nerve disease from any cause.
  • Use of contact lenses in the study eye(s).
  • 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, single dose. 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, single dose. Referred to as latanoprost.

Other names: XALATAN®

Primary outcomes

  1. Comfort Immediately After Dosing

    Time frame: 5 seconds

    Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2007
Registry last updated
May 18, 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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