Efficacy of T2259 in DED

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Vismed multi; Device: T2259

• Registration Number: NCT03874429
• Lead Sponsor: Laboratoires Thea

Brief Summary

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2019-04-24
• Primary Completion: 2021-02-12
• Study Completion: 2021-03-25
• Status Verified: 2022-06
• Results First Submitted: 2022-06-14
• Results First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Results First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vismed Multi	Vismed multi	1 drop in each eye 2 to 4 times daily
T2259	T2259	1 drop in each eye 2 to 4 times daily

Primary Outcome Measures

Name	Time	Method
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)	Baseline and Day 35	Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)

Trial Locations

Locations (1)

C.H.N.O des XV-XX; 🇫🇷 Paris, France