NCT05965778

Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome

Name: Clinical Trial NCT05965778
Creator: Laboratoires Thea
Keywords: Dry Eye, T2769, device, clinical trial

Laboratoires Thea·ClinicalTrials.gov·device·Device trialNot yet recruiting

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Study focus

Disease/Condition: Dry Eye
Drug/Device/Intervention: T2769
Study type: Interventional
Intervention type: device

Sponsor & location

Primary sponsor: Laboratoires Thea

Timeline & enrollment

Phase: N/A
Start date: Sep 01, 2023
End date: Aug 01, 2024
Enrollment: 226 participants

Primary outcome

Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme.

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.

ICD-10 classifications

Ocular painAvulsion of eyeOther corneal deformitiesCorneal ulcerDry mouth, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05965778
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT05965778 through Pure Global AI's free database. This phase not specified trial is sponsored by Laboratoires Thea and is currently Not yet recruiting. The study focuses on Dry Eye. Target enrollment is 226 participants.

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