Back to resultsEfficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
T2762
Vismed®
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T2762
Vismed®
Arm Description
Outcomes
Primary Outcome Measures
Global Ocular Staining (With Oxford Scale - Ranges : 0-15)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02023268
Brief Title
Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
Official Title
Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2762
Arm Type
Experimental
Arm Title
Vismed®
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
T2762
Intervention Description
1 drop in each eye 3 to 6 times daily during 84 days
Intervention Type
Device
Intervention Name(s)
Vismed®
Intervention Description
1 drop in each eye 3 to 6 times daily during 84 days
Primary Outcome Measure Information:
Title
Global Ocular Staining (With Oxford Scale - Ranges : 0-15)
Description
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).
Time Frame
Baseline and Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Clermont-Ferrand
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
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