NCT05931861

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	T2769	T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.

Timeline

• Start date: 2023-08-15
• Primary completion: 2023-12-04
• Completion: 2023-12-04
• First posted: 2023-07-05
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

6 sites across 1 country: Bulgaria