Clinical Investigation Of Buttermere Soft Contact Lenses.
Research type
Research Study
Full title
Clinical Investigation Of Buttermere(LENS271) Soft Contact Lenses.
IRAS ID
333019
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
The progression of myopia (near-sightedness) is becoming an epidemic. The key health issues are that higher the myopia poorer is the vision without correction and greater the risks of eye disease later in life. Several studies have shown that soft contact lenses with variable powers can slow the progression of myopia in children and adolescents, hence offering long term benefits. To slow down myopia, contact lenses must be worn most of the day; for this the contact lenses must achieve good visual acuity and good quality of vision.
To date there is only one CE marked contact lens marketed in the UK for the control of myopia progression MiSight® 1-day made from conventional hydrogel material. Young myopes could benefit from a contact lens made from silicone hydrogel material that carries more oxygen to the cornea. Cooper vision has developed a new silicone hydrogel contact lens with the same optical design as MiSight® 1-day made from Buttermere(LENS271).
The rationale for the is to compare the visual performance and safety of the new Buttermere(LENS271) to that of MiSight® 1-day to assess its potential benefits for young myopes.
The study will be conducted at a single site: 75 myopic children or adolescents (age 8 to 18 years) will be screened with a view that 70 will be enrolled and 60 will complete the study. The the participants will attend the clinic for four visit the study being in two phases:
i. In phase 1 the participants will wear in random order both contact lens types each for a period of one weak.
ii. In phase 2 the second contact lens test ed in phase 1 will be worn for a further three weeks.REC name
South West - Central Bristol Research Ethics Committee
REC reference
24/SW/0055
Date of REC Opinion
30 Apr 2024
REC opinion
Favourable Opinion