Clinical Acceptance of Soft Contact Lenses for Myopia Control
Research type
Research Study
Full title
Evaluation of Clinical Acceptance of Soft Contact Lenses for Myopia Control in Adolescents age 10 to 16 years old following 10 days of daily wear use.
IRAS ID
266562
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision, Inc.
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
The progression of myopia vision impairment or near-nearsightedness worldwide, including Europe, is becoming an epidemic. Several studies in the past five years have shown that soft multifocal contact lenses (MCL) or dual focus (DF)for children can slow the progression of myopia, providing a more effective and efficient treatment option. An important aspect of controlling myopia with contact lenses is that such contact lenses constitute the main correction modality and are worn most of the day by the myopic children. The ultimate objective when selecting a DF design to control myopic progression in children is to use the design that produces the highest level of control and can be accepted by the wearers. Therefore, it is essential to ensure that the various designs available are acceptable before starting a large long term study. The rationale for the proposed study is to establish over a relatively short time the acceptance of two DF designs available and the preferred lens. Up to 40 myopic adolescents (age 10 to 16 years) will be screened with a view to enrol 20 participants wearing 3 CE marked contact lenses (2 tests and 1 control) in a randomised order for a period of 10 days each on a daily wear basis. There will be five study visits over a 3 month period. Both participant and investigator (conducting the study measurements) will be masked. Overall subjective acceptance (likely to wear response, daily wearing time and visual satisfaction) will be used to compare the tests and control contact lenses.
REC name
West of Scotland REC 4
REC reference
19/WS/0099
Date of REC Opinion
10 Jul 2019
REC opinion
Favourable Opinion