Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
- Disease/Condition
- Dry Eye
- Drug/Device/Intervention
- T2769
- Study type
- Interventional
- Intervention type
- device
- Primary sponsor
- Laboratoires Thea
- Phase
- N/A
- Start date
- Aug 01, 2023
- End date
- Jan 01, 2024
- Enrollment
- 38 participants
Change from baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT05931861
- Type
- Device Trial
Access comprehensive clinical trial information for NCT05931861 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 38 participants.
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