Safety and efficacy of OPTIVE FUSION compared to VISMED® Multi Dry Eye
Research type
Research Study
Full title
A Multi-Centre, Investigator-Masked, Randomised, Controlled, Parallel-Group,Study to Compare the Safety and Efficacy of OPTIVE FUSION™ with VISMED® Multi for 3 Months in the Management of Dry Eye
IRAS ID
148149
Contact name
Michel Guillon
Contact email
Sponsor organisation
Allergan Pharmaceuticals
Clinicaltrials.gov Identifier
Research summary
A6-1
Dry eye syndrome occurs when the tear film does not adequately coat the surface of the eye. The condition produces discomfort and damage to the surface of the eye. The standard management of the condition is by way of eyedrops used several times a day; the efficacy of the eyedrops depends upon their composition and mode of action. The purpose of the study is to evaluate the safety and efficacy of a new eyedrop OPTIVE FUSION™, used 2 to 6 times a day over a three month period, compared with a standard reference eyedrop VISMED® Multi. The primary criterion to assess efficacy is the decrease in eye surface damage, evaluated with colouring agents which highlight the eye’s surface cells.
The study will be a multisite study involving approximately 80 participants with moderate to severe dry eye symptomatology and signs of eye surface dryness. The study will be carried out in France and the UK. This application is for the UK, where a single site will enroll a maximum of 8 participants. The study will involve three clinic visits (enrollment / dispensing; follow-up and exit) and a telephone monitoring call.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/0870
Date of REC Opinion
29 Jul 2014
REC opinion
Further Information Favourable Opinion