Efficacy and Safety Assessment of T1580 vs Vehicle in DED treatment
Research type
Research Study
Full title
Efficacy and Safety Assessment of T1580 versus Vehicle in Dry Eye Disease Treatment
IRAS ID
203782
Contact name
Frank LARKIN
Contact email
Sponsor organisation
Laboratoires THEA
Eudract number
2015-005405-36
Duration of Study in the UK
2 years, 4 months, days
Research summary
This study will involved menopausal patients with moderate to severe keratitis caused by dry eye disease (DED) which has not improved despite treatment with tear substitutes.
This study will include around 450 patients in several countries (in Europe and outside Europe) in multiple sites. The purpose of this study is to evaluate the efficacy of T1580 versus a vehicle for the treatment of moderate to severe keratitis caused by dry eye disease. The vehicle corresponds to a placebo, which is the same eye drop as T1580, but without ciclosporin. The study is designed to also evaluate the safety of T1580.
The study duration will be 1 year: in the first 6-month period, the patient will receive either T1580 or vehicle with 2 parallel groups followed by a 6-month treatment period during which all patients will receive T1580.REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/1458
Date of REC Opinion
19 Oct 2016
REC opinion
Further Information Favourable Opinion