Therapeutic fluid-gels for eye disease: Ocular Surface Disease (OPtiCS-OSD)
Research type
Research Study
Full title
Therapeutic fluid-gels for eye disease: Ocular Surface Disease. A Phase I/IIA safety trial evaluating allogeneic donor serum gel in patients with severe ocular surface disease (OPtiCS-OSD)
IRAS ID
1005852
Contact name
Saaeha Rauz
Contact email
Sponsor organisation
University of Birmingham
Research summary
Ocular surface disease (OSD) is a cause of eye discomfort. It is a complex condition that includes severe dry eye disease. Symptoms such as dryness and eye pain can lead to anxiety, and these can affect sight and wellbeing. Lubricating eye drops are used to relieve symptoms but these need to be applied frequently and their effects can be short-lived. Funded by the National Institute of Health and care Research (NIHR), the University of Birmingham has developed a new fluid-gel eyedrop containing blood serum (a standard treatment for severe OSD) which may stay on the eye surface for longer than current lubricating eye drops, thereby providing longer-term relief.
Phase 1 and 2 trials are done with a small number of people to see if an experimental treatment is safe. Our eyedrops are made up of products currently used in other eyedrop treatments used in clinical practice. The main aim of this trial is to investigate whether the gel-based eyedrop, alone (called ‘FLG-1001’) or containing serum (called ‘FLG-SED1’) can be applied safely to eyes. We also wish to know if the gel-based eyedrops are better at providing patient comfort by improving eye surface health more than the standard treatment; serum in saline (called ‘ATF-Allo-SED’ in this study).
We will do this in a 2-stage trial at the Birmingham & Midland Eye Centre: In Stage 1, six DED patients will receive each treatment for one day over three consecutive days. In Stage 2, 30 DED patients will be given (at random) either FLG-1001, FLG-SED-1 or ATF-Allo-SED for 42-days, followed by one extra visit one-week later. Safety will be measured by looking at how the treatments affect the eye surface and patient symptoms using clinical tests, patient diaries and questionnaires. Patients will use their current eye medication alongside the new treatments if needed.REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0064
Date of REC Opinion
17 Aug 2023
REC opinion
Further Information Favourable Opinion