Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®
Research type
Research Study
Full title
Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses
IRAS ID
173929
Contact name
Michel Guillon
Contact email
Sponsor organisation
Alcon Research Ltd.
Clinicaltrials.gov Identifier
A01648, Project number
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
In addition to providing sufficient oxygen to the ocular tissues, it is important for daily disposable soft contact lenses to maintain good wettability (tear coverage) and provide excellent visual performance throughout the wearing period. While the first silicone hydrogel daily disposable contact lenses introduced to the market exhibit high oxygen transmissibility, they typically suffer from poor wettability due to the inherent hydrophobic (water repelling) nature of the silicone polymer within the lens materials. Cooper Vision Inc. has modified the chemical composition of the silicone polymer in their MyDayTM lens by blending it with hydrophilic (water attracting) polymers.
The purpose of this study is to learn about the performance of the MyDayTM, lens and a traditional silicone hydrogel daily disposable contact lenses (1-DAY ACUVUE® TruEye®, manufactured by Johnson & Johnson Vision Care Inc.) and to assess whether the wettability and visual performance are improved for MyDayTM contact lenses compared to the traditional daily disposable silicone hydrogels. Both lens types will be worn for 10±3 days and measurements and assessments will be made after 3 hours of normal wear and following a period of 3 hours in a low humidity environment. The key areas of interest are functional vision and the wettability of the lens surfaces by the tear film in a normal environment and after exposure to the low humidity environment. Functional vision is assessed by a Time Controlled Visual Acuity (TCVA) test and wettability is assessed using an instrument designed to view the tear film (Tearscope).
The investigation will use a single site, prospective, observer masked, cross-over, randomized design. The study will be conducted at a research clinic in London, UK (OCULAR TECHNOLOGY GROUP – International (OTG-i)). In total approximately 60 participants (men and women at least 18 years of age) will be involved in the study.
REC name
London - Stanmore Research Ethics Committee
REC reference
15/LO/0421
Date of REC Opinion
13 Mar 2015
REC opinion
Favourable Opinion