Status:
UNKNOWN
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
Lead Sponsor:
Laboratoires Thea
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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 T2...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT05965778
Start Date
October 2 2023
End Date
August 1 2024
Last Update
April 29 2024
Active Locations (1)
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1
Gabriel-Montpied University Hospital
Clermont-Ferrand, France, 63003