Poly-ε-lysine hydrogel bandage contact lenses
Research type
Research Study
Full title
Poly-ε-lysine hydrogel bandage contact lenses
IRAS ID
313495
Contact name
Stephen Kaye
Contact email
Sponsor organisation
Research and Development, Royal Liverpool University Hospital
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
We have developed a novel hydrogel, poly-epsilon-lysine hydrogel contact lens (pCL), with a high-water content, excellent transparency and mechanical properties similar to those of existing hydrogel contact lenses. Poly-epsilon-lysine is an edible, non-toxic material currently used as an emulsifier and preservative in foodstuffs and for the pharmaceutical industry and classified as ‘generally regarded as safe’ (GRAS) by the U.S. Food and Drug Administration since 2004. The specific advantage of this new hydrogel is that it has natural antimicrobial properties, unlike any of the existing materials. The hydrogel is formed in water at room temperature, whereas existing contact lens materials require the use of toxic acrylic monomers solvents and reagents during manufacture and then need extensive washing procedures to remove them. In addition, normal contact lenses require considerable mechanical processing during manufacture
Currently available commercial contact lenses are manufactured from acrylic and silicone-based monomers, derived from the petroleum industry and to non-sustainable fossil fuels. In addition, the existing monomers are toxic and carcinogenic and their polymerisation generates toxic by-products, which have to be removed by exhaustive washing procedures.
Although animal-derived collagen lenses have been used as bandage contact lenses they require a complex manufacturing process, resulting in variable products.
We hypothesise that a contact lens made from a poly-epsilon-lysine hydrogel can be safely worn as a bandage contact lens. The primary objective is to evaluate safety of this bandage contact lens in healthy volunteers with no previous or ongoing history of corneal or ocular surface disease.
REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0568
Date of REC Opinion
11 Nov 2022
REC opinion
Further Information Favourable Opinion