Phase III Clinical Trial of TRAVATAN Z… | Clinical Trial

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 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

18 years or older.
Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logMAR or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
Use of contact lenses within 30 days of Visit 1.
Use of contact lenses during the study.
Participation in an investigational drug or device study within 30 days of entering this study.
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 90 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 90 days. Referred to as latanoprost.

Other names: XALATAN®

Primary outcomes

Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score

Time frame: Day 0, Day 90

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. A negative number represents a perceived improvement in ocular health.

Secondary outcomes

Percentage of Patients With Corneal Fluorescein Staining Score = 0

Time frame: Day 90

The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Sep 29, 2008
Registry last updated: Apr 26, 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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Completed