STUDY LT4020-PIII-12/11 - Application Form updated on the 29/01/2013
Research type
Research Study
Full title
Efficacy and Safety assessment of T4020 versus vehicle in patients with chronic neurotrophic keratitis or corneal ulcer. Phase III study, international, multicentre, randomised, double-masked, 2 parallel groups, versus vehicle, in 124 evaluable patients treated for 28 days.
IRAS ID
125247
Contact name
Francisco FIGUEIREDO
Contact email
Sponsor organisation
THEA Laboratories R&D Dpt
Research summary
The purpose of the study is to demonstrate the efficacy and safety of CALCICOL20 compared to vehicle in patients with chronic neurotrophic keratitis or corneal ulcer.
Each patient will be randomly assigned to one of the two treatment groups (CALCICOL20 or vehicle) using a 2:1 allocation ratio.
The proposed 28 days study is a multicentre, international, randomised, double-masked, 2 parallel groups versus vehicle.
At least 124 adult patients will be randomized in the study.
The ultimate aim of the study is to demonstrate the superiority of CALCICOL20® eye drops over vehicle in patients with chronic neurotrophic keratitis or corneal ulcer.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0086
Date of REC Opinion
21 May 2013
REC opinion
Further Information Favourable Opinion