Phase 3
N=705
Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
Open-angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00761319 ↗Enrolled (actual)
705
Serious AEs
1.4%
Results posted
Apr 2012
Primary outcome: Primary: Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score — -9.1; -10.2 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) (Drug); Latanoprost ophthalmic solution 0.005% (XALATAN®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score |
-9.1; -10.2 | — |
| SECONDARY Percentage of Patients With Corneal Fluorescein Staining Score = 0 |
37.6; 38.7 | — |
Summary
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00761319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.