Evaluation efficacy and safety of DM934 versus Théalose in dry eye
Research type
Research Study
Full title
Multi-centric, randomised, comparative clinical study on the evaluation of the efficacy and safety of DM934 versus Théalose on the treatment of moderate to severe ocular dryness.
IRAS ID
335464
Contact name
Michel Guillon
Contact email
Sponsor organisation
HORUS PHARMA
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Dye eye disease (DED) is affecting a large portion of the population and its prevalence increasing, in part due to two important contributing factors ageing and the use of electronic devices. While DED is in part defined by patients symptoms, its causes are multiple leading to different unwanted effects on the tear film requiring different management approaches. The mainstay treatment is the use of eyedrops aiming to improve the tear film and protect the surface of the eye. The tear film, is a three-layer structure, therefore, eyedrops need to target improving all three layers or a least specifically one. One component extensively used is sodium hyaluronate (HA) which targets the aqueous layer (watery part) of the tear film improving its physical properties. Another component is Trehalose , which targets the surface of eye by helping the epithelium to recover in case of damage. A novel component that improves hydration (keeping the surface of the eye moist) is D-Panthenol. Combined with the previous two components D-Panthenol has shown to have a potentially enhanced effect on dry eye; the three components being the basis of DM934 eyedrop a class IIa medical device CE-marked for use up to one month.
DED is a chronic disease, hence, its management needs to be longer than a single month. The objective of this study is to compare over a three-month period DM934 eyedrop with a CE marked eyedrop, Théalose, containing only sodium hyaluronate and trehalose. The basis of the comparison will be improvement in ocular signs and symptoms, on patients with moderate to severe ocular dryness.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0268
Date of REC Opinion
22 Jan 2024
REC opinion
Further Information Favourable Opinion