Short-Term Clinical Evaluation of SEED 1-Day Pure Moisture Lens
Research type
Research Study
Full title
Short-Term Clinical Evaluation of SEED 1-Day Pure Moisture Lens
IRAS ID
216604
Contact name
Nancy Keir
Contact email
Sponsor organisation
CooperVision Inc,
Duration of Study in the UK
0 years, 0 months, 28 days
Research summary
The purpose of this study is to determine the impact of Alginic acid release on the pre-lens tear film of symptomatic contact lens wearers by comparing the short-term clinical performance of the normal SEED 1-Day Pure Moisture lens with and without prior soaking.
This will be an approximate 10-25 subject, contralateral (subjects will wear a test lens in one eye and control lens in the other), randomised, double-masked, one-day dispensing study used to compare the lens treatments. Each subject will wear a test lens and a control lens for approximately 6 hours and will be assessed at 7 different time-points; at baseline, after 5, 10, 30, 60 and 120 minutes, and at 6 hours.
Participants will be existing soft contact lens wearers recruited on the basis of having healthy eyes apart from needing correction for shortsightedness. Participants will be screened for being symptomatic contact lens wearers i.e. they will have a comfortable wearing time 2 hours less than the average wearing time or experience symptoms of late day dryness and only those deemed symptomatic will be dispensed lenses in the study. Participants will need to attend the study site on two occasions in one day.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1935
Date of REC Opinion
17 Oct 2016
REC opinion
Favourable Opinion