Back to resultsEfficacy of T2259 in DED
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
T2259
Vismed multi
Sponsored by
About this trial
This is an interventional other trial for Dry Eye Syndromes
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
Exclusion Criteria:
- Far best-corrected visual acuity≤2/10
- Severe Blepharitis
Sites / Locations
- C.H.N.O des XV-XX
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T2259
Vismed Multi
Arm Description
1 drop in each eye 2 to 4 times daily
1 drop in each eye 2 to 4 times daily
Outcomes
Primary Outcome Measures
evaluation of ocular staining grade
Oxford score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03874429
Brief Title
Efficacy of T2259 in DED
Official Title
Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
February 12, 2021 (Actual)
Study Completion Date
March 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2259
Arm Type
Experimental
Arm Description
1 drop in each eye 2 to 4 times daily
Arm Title
Vismed Multi
Arm Type
Active Comparator
Arm Description
1 drop in each eye 2 to 4 times daily
Intervention Type
Device
Intervention Name(s)
T2259
Other Intervention Name(s)
HA and Trealose
Intervention Description
HA and Trealose
Intervention Type
Device
Intervention Name(s)
Vismed multi
Other Intervention Name(s)
HA
Intervention Description
HA
Primary Outcome Measure Information:
Title
evaluation of ocular staining grade
Description
Oxford score
Time Frame
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
Exclusion Criteria:
Far best-corrected visual acuity≤2/10
Severe Blepharitis
Facility Information:
Facility Name
C.H.N.O des XV-XX
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
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Efficacy of T2259 in DED
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