Clariti™ 1Day Multifocal Contact Lenses Clinical Evaluation
Research type
Research Study
Full title
CLARITI™ 1DAY MULTIFOCAL CONTACT LENSES PERFORMANCE & ACCEPTANCE EVALUATION
IRAS ID
128166
Contact name
Michel Guillon
Contact email
Sponsor organisation
Johnson & Johnson Vision Care Inc
Research summary
The purpose of this study is to assess the performance and acceptance of a new multifocal contact lens Clariti™ 1day multifocal to correct vision in presbyopic patients (people who require different vision corrections for distance and near vision). The evaluation will take place over a one week period of daily disposable, daily wear(the contact lenses are removed before sleep and discarded and a new, identical pair of contact lenses is used the following day). The test and control contact lenses will be used in turn by all the study participants. The aim of the evaluation is to quantify the difference between the test correction and the reference control. It is estimated that 40 adult participants, above the age of 45 years who wear spectacles or soft contact lens, will be recruited. Two presbyopic populations will be enrolled depending on near spectacle addition and each population will comprise 20 subjects.
01 - Participants with established presbyopia (moderate power near vision additions)
02 - Participants with advanced presbyopia (high power near vision additions)
Subject’s participation in the study will last approximately 16 - 30 days. During this time, the investigators will carry out a range of clinical tests to precisely measure the vision achieved and the fit of the contact lenses, examine the participants’ eyes; the participants will also be asked to rate the lens performance.
The study will be conducted at one optometrist centre in UK being sponsored by Johnson and Johnson Vision Care Inc.REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0041
Date of REC Opinion
14 Mar 2014
REC opinion
Further Information Favourable Opinion