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Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

Dry Eye Clinical Trial

Official title:
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05931861
Study type Interventional
Source Laboratoires Thea
Contact
Status Completed
Phase N/A
Start date August 15, 2023
Completion date December 4, 2023
View Details
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