Clinical trials - recruiting subjects
DOORS Press Release
A new health study is to be launched in a bid to help millions who suffer from ‘dry eye’.
One in four of us will suffer from the debilitating condition with symptoms ranging from sore eyes through to short-term blurred vision.
Now experts based in Birmingham and Nottingham are looking for people to take part in the study, wearing a special contact lens for under 2 weeks, which could lead to longer term relief.
Volunteers are being sought for the research which is being conducted by Aston University’s Eye Clinic in collaboration with Nottingham’s NuVision Biotherapies, a company formed with backing of the University of Nottingham.
The study follows the development of an eyesight-saving product, Omnigen, derived from human amniotic membrane donated from caesarean sections. Up until recently it could only be applied surgically but NuVision have created OmniLenz.
This bespoke contact lens allows the surgery-free application of Omnigen. Such a simple, 5-minute procedure enables eyecare professions to treat ocular surface diseases, as simply as applying a contact lens, early and more effectively without the need for surgery.
Professor James Wolffsohn, principle investigator of the study, said: “Dry eye can be a severe, chronic and debilitating disease. Amniotic membrane has shown great promise in its management, but retention on the eye is required. We want to see how we can help people with dry eye by applying this lens.
“Omnigen is already successfully used throughout the NHS and the study aims to demonstrate that the wound healing benefits of Omnigen are easily transferable to those suffering and living with dry eye disease.”
This trial is designed as a prospective, double-arm, investigational randomised study to examine the change in dry eye disease symptoms and pathology following the in-clinic OmniLenz transplantation of Omnigen for patients suffering from moderate to severe dry eye disease.
Founder and Chief Scientific Officer of NuVision, Dr. Andrew Hopkinson, said: “Amniotic membrane has clinically proven wound healing capability which historically has been reserved for severe surgical situations. Through the innovation of OmniLenz application of Omnigen in an out-patient setting, NuVision is already helping to treat patients with severe ocular surface injuries. However, this clinical trial now aims to demonstrate a benefit to those suffering from dry eye disease.”
NuVision received support from the INSTILS project – part-funded through the European Regional Development Fund (ERDF) and delivered by Medilink East Midlands. Thanks to INSTILS support, NuVision received an Innovation Support Grant, to the value of £12,920, which will allow them to undertake this study with Aston University, accelerating the clinical trial process and bringing NuVision’s novel approach to market faster than would have otherwise been possible.
Darren Clark, Chief Executive of Medilink East Midlands, said: “NuVision has a truly innovative and outstanding approach to treating dry eye disease. I am confident that the help we’ve given to them, both in terms of the Innovation Support Grant and the dedicated time and effort that one of our Innovation Advisers has invested in them, will make their treatment available quicker, improving outcomes for patients worldwide.”
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