Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms. - Trial NCT05931861
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Study Focus
Sponsor & Location
Laboratoires Thea
Timeline & Enrollment
N/A
Aug 01, 2023
Jan 01, 2024
Primary Outcome
Change from baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.
Summary
This is a confirmatory clinical investigation. The objective is to collect new additional
 clinical data demonstrating the safety and performance of the device in the contact-lens
 wearing population with dry eyes. The hypotheses are that T2769 improves dry eye
 symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by
 VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in
 comparison to baseline.
 
 The primary objective of this investigation is to assess the performance of T2769 in contact
 lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final
 visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05931861
Device Trial