Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
Research type
Research Study
Full title
A Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
IRAS ID
188133
Contact name
Lee A Hall
Contact email
Sponsor organisation
Coopervision Inc.
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
The purpose of this study is to compare the subjective performance of two different brands of soft contact lenses worn on a daily wear basis. Each brand of lens will be worn for a 4 week period. Both brands are CE marked/FDA approved products i.e. approved for use in the European Union and the United States.
This is a 90 participant, single-masked (participants will be masked to lens type and investigators will be masked to the lens coding), cross-over dispensing study. Participants will wear one brand for a period of 4 weeks and then change to wear the second brand for a period of 4 weeks.
The study will be conducted at three optician practices in England and two in the USA. The study is being sponsored by CooperVision Inc.
Participants will be existing soft contact lens wearers recruited on the basis of having healthy eyes apart from needing correction for short-sightedness. Participants will need to attend the study site on five occasions for approximately 30-40 minutes per visit over a period of approximately 8 weeks.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0372
Date of REC Opinion
10 Aug 2015
REC opinion
Favourable Opinion