Status:
COMPLETED
Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
Lead Sponsor:
Alcon Research
Conditions:
Open-angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
705 Patients enrolled
Trial Details
Trial ID
NCT00761319
Start Date
October 1 2008
End Date
September 1 2009
Last Update
April 26 2012
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