Evaluation of efficacy & safety of Vismed eyedrop on ocular dryness
Research type
Research Study
Full title
Evaluation of the efficacy and safety of Vismed® Gel % Multi 0.3% versus Vismed® Multi 0.18% on the treatment of moderate to severe ocular dryness
IRAS ID
247880
Contact name
Ali Mearza
Contact email
Sponsor organisation
Laboratoires Horus Pharma
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Sodium hyaluronate (Hyaluronate Acid (HA) eyedrops are used extensively in patients complaining of dry eye. Higher concentration HA eyedrop may have greater impact than lower HA concentration eyedrop, hence better relief. The purpose of this study is to compare the efficacy and safety of Vismed 0.3% HA eyedrop (Test) with Vismed 0.18% HA eyedrop (Control) for improvement of ocular dryness signs and symptoms, on subjects with moderate to severe ocular dryness for a period of 1 and 3 months. Evaluation will include ocular staining score, dry eye questionnaire, schirmer test, non-invasive tear break up time (NIBUT), subjective dryness symptoms, eyedrop performance and frequency of use. Approximately 80 people will take part in this study across multiple sites in EU (France, Poland, Spain and United-Kingdom). The study in UK will involve twenty moderate to severe dry eye sufferers. There will be four study visits over 3.5 months period. Subjects will be given saline artificial tears for a 1-2 week wash out period prior to entering the treatment phase. During the 3 month treatment phase, subjects will be randomized in 1:1 ratio into 1 of 2 treatment arms (Test or Control)and will use the assigned study eyedrop daily, 1 to 2 drops in each eye, 4 to 6x per day. The investigator will be masked. Subjects will be evaluated after one and three months use of the assigned study eyedrops.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0196
Date of REC Opinion
19 Jun 2018
REC opinion
Further Information Favourable Opinion