Clinical Acceptance and Performance of Hercules Contact Lenses
Research type
Research Study
Full title
Validation Study of the Clinical Acceptance and Performance of Hercules Soft Contact Lenses
IRAS ID
296709
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited (CVIL)
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
The progression of myopia vision impairment or near-sightedness worldwide, is becoming an epidemic. Several studies have shown that soft multifocal contact lenses for children can slow the progression of myopia, which is important: the higher the myopia the poorer is the vision without correction and the greater are the risks of eye disease later in life.
To control myopia contact lenses must be worn most of the day by children and adolescents. CooperVision has commercialised MiSight® 1-day which is well accepted by adolescents and demonstrated a 59% decrease in myopia progression over a three-year period. MiSight® 1-day contact lenses are made in an hydrogel material (omafilcon A) and CooperVision wishes to develop a similar contact lens in a silicone hydrogel material (somofilcon A); the key benefit of the silicone hydrogel material is that it transmits more oxygen to the cornea affording greater eye health during long term wear.
The safety of somofilcon A material has been demonstrated as it is the material of the clariti family of CE marked contact lenses. The rationale for the study is to demonstrate in short term study that the optical design of MiSight® 1-day applied to somofilcon A material achieves a visual performance that is non inferior and that MiSight® 1-day.
The study will be conducted at a single site in central London where up to 90 myopic adolescents (age 8 to 18 years) currently wearing contact lenses will be screened with a view that 67 will enrolled and 61 will completed the study. The participants will wear in turn in a random fashion the two contact lens types for approximately 10 days each and will attend the clinic on three occasions. Vision and comfort will be measured and both the participants and investigators will be masked to avoid bias.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0074
Date of REC Opinion
17 May 2021
REC opinion
Further Information Favourable Opinion