Efficacy, Safety of T2769 in Dry Eye Disease

Not Applicable

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Other: T2769

• Registration Number: NCT03830359
• Lead Sponsor: Laboratoires Thea

Brief Summary

Efficacy of T2769 in Dry Eye Desease

Detailed Description

Multicenter and open study

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-05
• Primary Completion: 2019-02-18
• Study Completion: 2019-02-18
• Status Verified: 2019-08
• Results First Submitted: 2020-09-18
• Results First Submitted QC: 2021-12-15
• Results First Posted: 2022-03-04
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Signed and dated informed consent
• Male or female aged from ≥ 18 years old
• Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening

Exclusion Criteria

• Best far corrected visual acuity ≤ 2/10
• Severe blepharitis Severe dry eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T2769	T2769	T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily

Primary Outcome Measures

Name	Time	Method
Ocular Symptomatology	Baseline and Day 42	Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.

Trial Locations

Locations (3)

Hôpital Universitaire Tahar Sfar; 🇹🇳 Mahdia, Tunisia

"Hôpital Universitaire Fattouma Bourguiba; 🇹🇳 Monastir, Tunisia

"Hôpital de Forces de Sécurité Intérieure La Marsa; 🇹🇳 Tunis, Tunisia