Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease Treatment

Phase 1

• Conditions: Dry Eye; MedDRA version: 20.0 Level: LLT Classification code 10013778 Term: Dry eyes System Organ Class: 100000004853; MedDRA version: 20.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-005405-36-PL
• Lead Sponsor: aboratoires Théa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

Informed consent signed and dated
Menopausal woman
Patient with BILATERAL persistent DED

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Presence of an active condition :
a. Ocular rosacea, uveitis,
b. Abnormal eye lid anatomy, blinking, or naso-lachrymal drainage system,
c. Ocular hypertension or glaucoma requiring an ophthalmic medicinal product,
d. Infectious conjunctivitis, severe blepharitis, and/or progressive pterygium.
Major corneal hypoaesthesia value = 20 mm as measured with a Cochet-Bonnet aesthesiometer.
Far best corrected visual acuity (BCVA) worse than or equal to + 0.7 LogMar.
Any history of, or active, relevant ocular disorder condition other than those listed above which is likely to interfere with the study results as judged by the investigator at Screening or Baseline visits. Any ophthalmic disease likely to change the assessment of fluctuating blurred vision linked to dry eye disease or may result in a visual acuity deterioration in the following year.

Other exclusion criteria are defined in the protocol (Exclusion criteria regarding ocular history, Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the efficacy of T1580 versus vehicle in Dry Eye Disease (DED).;Secondary Objective: The secondary objective is to evaluate the safety of T1580.;Primary end point(s): The change from Baseline in Corneal Fluorescein Staining (CFS);Timepoint(s) of evaluation of this end point: Assessed at Month 6

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Key Secondary efficacy Endpoints<br> -CFS response to treatment<br> -Combined CFS and OSDI response to treatment<br><br> ;<br> Timepoint(s) of evaluation of this end point: Assessed at Month 6<br><br>