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
Conditions
Sponsors
Laboratoires Théa
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Assessed at Month 6; 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).; Main Objective: The primary objective of this study is to evaluate the efficacy of T1580 versus vehicle in Dry Eye Disease (DED). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary efficacy Endpoints -CFS response to treatment -Combined CFS and OSDI response to treatment ; Timepoint(s) of evaluation of this end point: Key Secondary efficacy Endpoints Assessed at Month 6 | — |
Countries
Armenia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Greece, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom
Contacts
Public ContactClinical department
Laboratoires Thea
Outcome results
None listed