Clinical Evaluation of Oté Sensation Solution Care System
Research type
Research Study
Full title
One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System.
IRAS ID
227811
Contact name
Frances Louise Nicklin
Contact email
Sponsor organisation
OTE North America
Duration of Study in the UK
0 years, 1 months, 21 days
Research summary
The purpose of the study is to evaluate the clinical performance of the contact lens care product- Oté Sensation Solution Care System. Another soft contact lens multi-purpose solution- BioTrue (Bausch&Lomb) will be used as a control during this study. Both types of solutions are CE marked and marketed in Europe.
Approximately 10 sites will be involved in this study in the UK and US (3-5 UK and 5-6 US) and each site is expected to enrol approximately 20 subjects.
This double masked (care product), bilateral, randomised, comparative study is being sponsored by OTE North America.
The subjects will be provided with the contact lenses to wear for the duration of the study. There will be six types of lenses available: ACUVUE® 2 (Johnson & Johnson Vision Care), ACUVUE® VITA®, Air OPTIX® (Alcon), Biofinity® (CooperVision), PureVision® (Bausch & Lomb), Clariti (CooperVision). All types have been CE marked. Approximately 33 subjects will be allocated to use each lens type, of which 22 will use the test solution and 11 will use the control solution.
Each subject will be expected to attend up to four scheduled study visits over a period of approximately a month. The subjects will be currently adapted soft contact lens wearers with healthy eyes but in need of correction for short- or long-sightedness.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0378
Date of REC Opinion
26 Jul 2017
REC opinion
Favourable Opinion