Clinical Acceptance of Soft Contact Lenses for Myopia Control
Research type
Research Study
Full title
Evaluation of the clinical acceptance of soft contact lenses for myopia control
IRAS ID
288427
Contact name
Ruchi Gupta
Contact email
Sponsor organisation
CooperVision, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
The progression of myopia vision impairment or near-near-sightedness worldwide, including Europe, is becoming an epidemic. Several studies in the past five years have shown that soft multifocal (MCL) or dual focus (DF) contact lenses for children can slow the progression of myopia, which is important as the higher the myopia the poorer is the vision without correction and the greater are the risks of eye disease later in life.
To be efficient at controlling myopia the contact lenses must be worn most of the day by children and adolescents. The ultimate objective when selecting a DF design to control myopic progression is to use a design that produces the highest level of control and can be well accepted visually by the children and therefore worn most of the day. As the studies to demonstrate the efficiency of contact lenses to control myopia typically involve several hundred children in long term studies lasting several years, it is essential to ensure that the designs progressing to long term studies are visually acceptable.
The rationale for the proposed study is, therefore, to establish over a relatively short time that the visual acceptance of two new DF designs is not inferior to the visual acceptance of the control design that has been used successfully for several years. For this up to 40 myopic adolescents (age 10 to 16 years) will be screened with a view to enrol up to 30 participants wearing the three CE marked contact lenses (2 tests and 1 control) in a randomised order for a period of 10 days each. The study will involve five study visits over a 3-month period. Both participants and investigators (conducting the study measurements) will be masked. Overall visual acceptance will be used to compare the contact lenses.REC name
London - Surrey Research Ethics Committee
REC reference
20/PR/0484
Date of REC Opinion
24 Nov 2020
REC opinion
Further Information Favourable Opinion