Neovis® Total Multi versus Systane® Balance in MGD
Research type
Research Study
Full title
Multicentric, randomized, comparative clinical study on the evaluation of the efficacy and safety of Neovis® Total Multi versus Systane® Balance on the treatment of ocular dryness associated with meibomian gland dysfunction
IRAS ID
309011
Contact name
Michel Guillon
Contact email
Sponsor organisation
Horus Pharma
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
Dry eye is the most common eye condition leading to an appointment with an eye care professional and its frequency increases rapidly due to population aging and increase use of computers and other electronic devices. There are two major causes of dryness: i. insufficient supply of tear by the lachrymal gland (called aqueous dry eye) and ii. abnormal production of oil by the glands (meibomian glands) situated along the eyelid borders which role is to prevent the tear film to dry up between blinks (evaporative dry eye).
The latter type is by far the most common cause being present in 80% of dry eyes. Due to environmental factors and aging the glands get blocked so either do not produce enough oil or do not produce the correct type of oil. The standard treatment is to warm the eyelids and then clean the eyelid borders with medicated wipes. Even though the treatment improve the situation it does completely resolve the problem and oil containing eyedrop (lipid emulsion) needs to supplement the natural tears to prevent exercise tear evaporation.
The current study aim to demonstrate that a new emulation formulation (Neovis® Total Multi) is not inferior in stabilizing the tear film in patients with abnormal meibomian glands (meibomian gland dysfunction (MGD)) than an existing emulsion (Systane® Balance) which efficacy has been proven in MGD. The study will compare the effect of the two emulsions on two group of MGD sufferers randomly selected in terms of tear film stability and signs and symptoms of dry eye.REC name
London - Riverside Research Ethics Committee
REC reference
21/PR/1697
Date of REC Opinion
18 Feb 2022
REC opinion
Further Information Favourable Opinion