Clinical Evaluation of ACUVUE® OASYS® 1-DAY and ACUVUE® OASYS®
Research type
Research Study
Full title
Clinical Evaluation of ACUVUE® OASYS® 1-DAY Daily Disposable Silicone Hydrogel Contact Lenses
IRAS ID
201516
Sponsor organisation
Alcon Research Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 28 days
Research summary
A new daily disposable (DD) silicone hydrogel lens (AO1D) was launched by Johnson & Johnson Vision Care in the US in October 2015. The technical specifications of AO1D show very few differences compared to the AO contact lenses currently marketed for replacement intervals of up to 2-weeks. The two contact lenses are both made from senofilcon A material with a 38% water content and have similar physical properties. However, the new DD silicone hydrogel lens has some design changes including a larger lens diameter, greater optic zone diameter and flatter curvature.
It is hypothesized that the performance of AO1D would be very similar to AO when it is worn as a DD lens, in particular for clinical endpoints driven by material characteristics. Hence it is of interest to evaluate the clinical performance of AO1D and AO silicone hydrogel contact lenses to determine the factors driving the clinical performance of AO1D and to measure clinically the effect of the design modifications described above, in a group of current DD lens wearers. The key areas of interest will be the evaluation of tear film related clinical endpoints in a normal environment and after exposure to a low humidity environment, lens fitting characteristics and subjective ratings of both lenses after at least 7 days of wear on a daily disposable modality.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/0383
Date of REC Opinion
28 Feb 2016
REC opinion
Favourable Opinion