Back to resultsComparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
Primary Purpose
Dry Eye
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
T2769
Vismed® Multi
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria: Informed consent signed and dated (obtained prior to initiating any procedures). Patient aged ≥18 years old. Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit. Surface Disease Index (OSDI) Score ≥ 23. Ocular discomfort evaluated by VAS ≥ 40 mm. Exclusion Criteria: Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study). Severe blepharitis according to the judgment of the investigator Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T2769
Vismed® Multi
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme.
The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme at D36 in the study eye.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05965778
Brief Title
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
Official Title
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
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
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.
To evaluate the performance and safety of T2769 versus Vismed® Multi.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T2769
Arm Type
Experimental
Arm Title
Vismed® Multi
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
T2769
Intervention Description
T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
Intervention Type
Device
Intervention Name(s)
Vismed® Multi
Intervention Description
Hyaluronic acid
Primary Outcome Measure Information:
Title
Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme.
Description
The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme at D36 in the study eye.
Time Frame
Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent signed and dated (obtained prior to initiating any procedures).
Patient aged ≥18 years old.
Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.
Surface Disease Index (OSDI) Score ≥ 23.
Ocular discomfort evaluated by VAS ≥ 40 mm.
Exclusion Criteria:
Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).
Severe blepharitis according to the judgment of the investigator
Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corentin LE CAMUS
Phone
+33473981436
Email
Corentin.LECAMUS@theapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric CHIAMBARETTA, Prof.
Organizational Affiliation
Individual Practice for Specialized Ophthalmology Care
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
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