Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease Treatment
- Conditions
- Dry EyeMedDRA version: 20.0 Level: LLT Classification code 10013778 Term: Dry eyes System Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]MedDRA version: 20.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853
- Registration Number
- EUCTR2015-005405-36-LT
- Lead Sponsor
- aboratoires Théa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
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
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 Timepoint(s) of evaluation of this end point: Assessed at Month 6;<br> Secondary Objective: The secondary objective is to evaluate the safety of T1580.<br> ;Primary end point(s): The change from Baseline in Corneal Fluorescein Staining (CFS).;<br> Main Objective: The primary objective of this study is to evaluate the efficacy of T1580<br> versus vehicle in Dry Eye Disease (DED).<br>
- 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> Timepoint(s) of evaluation of this end point: Key Secondary efficacy Endpoints<br> Assessed at Month 6<br>