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Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open-angle Glaucoma; Ocular Hypertension

Intervention: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) (Drug); Latanoprost ophthalmic solution 0.005% (XALATAN®) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome: Percentage of Patients With Corneal Fluorescein Staining Score = 0

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: October 2008
Last updated: April 20, 2012

Page last updated: August 23, 2015

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