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
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