Neovis Total Multi - Clinical Performance & Acceptance
Research type
Research Study
Full title
Neovis® Total Multi Eyedrop - Characterisation of clinical performance and acceptance in Adults with dry eyes following topical ocular use for 4-weeks.
IRAS ID
272716
Contact name
Kishan Patel
Contact email
Sponsor organisation
Laboratoires Horus Pharma
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
The global prevalence of dry eye disease reported in several large studies ranges from 5% to 35% (Anon 2007), with meibomian gland dysfunction reported in about 70% of dry eye cases (Stapleton et al 2017). The use of eyedrop products, which attempt to replace and/or supplement the deficient natural tear film, is the mainstay treatment option in the management of dry eye disease. However eyedrops are not all the same, varying greatly in their composition, osmolarity, structure and intended benefits.
Neovis® Total Multi (CE-marked) incorporates components that target all three layers of the tear film. Other studies have demonstrated the efficacy of this eyedrop. The proposed study intends to fully characterise the short-term (single instillation -phase 1) and repeated use over one month (phase2) clinical performance and acceptance of the eyedrop by quantifying the changes in tear film characteristics, ocular tissues and subjective responses in moderate to severe dry eye sufferers compared to not using the eyedrop (baseline). Specifically, how much changes in tear film characteristics, ocular tissues characteristics are produced, how long the changes occurred post instillation and after one-month of daily use. The effect on subjective comfort, vision and symptoms will be evaluated. Up to 60 adults with moderate to severe dry eye will be screened with the intention to have 40 participants enrolled and completed the study. There will be up to three study visits over a six-week period.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0315
Date of REC Opinion
11 Nov 2019
REC opinion
Further Information Favourable Opinion