Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
Phase 3
Completed
- Conditions
- Dry Eye Syndrome
- Interventions
- Device: Vismed®Device: T2762
- Registration Number
- NCT02023268
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
- Signed and dated informed consent
- Male or female aged from ≥ 18 years old.
- Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.
Exclusion Criteria
- Best far corrected visual acuity < 1/10
- Severe blepharitis
- Severe Dry Eye
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vismed® Vismed® - T2762 T2762 -
- Primary Outcome Measures
Name Time Method Global Ocular Staining (With Oxford Scale - Ranges : 0-15) Baseline and Day 35 Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).
- Secondary Outcome Measures
Name Time Method