Assessing Fitting Guides in Alcon Multifocal Contact LensesCLK027-P001
Research type
Research Study
Full title
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
IRAS ID
226800
Contact name
Laura J. Nixon
Contact email
Sponsor organisation
Alcon Research Ltd. (Alcon Laboratories Inc.)
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
Some eye care practitioners avoid offering their patients multifocal contact lenses due to the perceived impression of the added time it takes to fit these lenses.
The goal of this study is to collect data on 2 fitting guides (current and alternative)for multifocal contact lenses to create a fitting guide which would reduce the amount of time needed to fit the lenses and will optimize patient outcomes.
The study will be conducted at approximately 20 sites worldwide (USA, Canada and UK).
Each site will enroll approximately 9 subjects, approximately 180 subjects who are current wearers of soft contact lenses for correction of presbyopia will be enrolled in the study.
The expected duration of the subject's participation is 7-33 days. The participants will have a minimum of 2 scheduled visits, and a maximum of 5 scheduled visits, depending on the necessity to optimize their prescription.
Upon signing the informed consent form, subjects will be considered enrolled in the study and will be assigned a number in the appropriate numerical sequence.Randomization for this study will be implemented in 2 parts. First, each site will be
randomized to one fitting guide and will fit all subjects at their site using the assigned fitting guide (current or alternative). Randomization of the fitting guide will be stratified by region. Secondly, subjects who currently wear monthly/weekly contact lenses will be randomized to either AIR OPTIX AQUA® or DAILIES® AquaComfort Plus® contact lenses (1:1 randomization). Subjects who currently wear daily disposable contact lenses will be fitted with DAILIES TOTAL1® Multifocal contact lenses.
The study lenses will be dispensed in an unmasked manner by a trained study staff member. Participants will know which study lenses they will receive, but will not know which fitting guide will be used to fit the lenses.REC name
Wales REC 7
REC reference
17/WA/0124
Date of REC Opinion
26 Apr 2017
REC opinion
Unfavourable Opinion