Proactive management to improve symptomatic CL wearers success
Research type
Research Study
Full title
Understanding the impact of 1-year proactive management to improve symptomatic contact lens wearers success in healthy adult participants. \n
IRAS ID
266960
Contact name
Kishan Patel
Contact email
Sponsor organisation
CooperVision, Inc.
Duration of Study in the UK
1 years, 3 months, 26 days
Research summary
Contact lens discomfort affects 30 to 50% of contact lens wearers. The condition is specific to contact lens wear, because when the contact lens is removed at the end of the wearing day, ocular comfort recovers very rapidly. The significant cause is believed to be due to the effect of the contact lens on the tear film.\nTo date no study has specifically tested the contribution of slight to mild anomalies of the tear film and /or the ocular tissues and symptomatology in contact lens wearers. The rationale for the current study is to explore the potential benefit of proactively managing any tear film or ocular tissue anomalies of any severity of symptomatic individual contact lens wearers using proactive management beyond standard of care typical of current clinical practice. Insights from this study may be used to improve future contact lenses and/or contact lens management strategies for eye care practitioners. \nUp to 90 participants will be enrolled in this proof of concept, early feasibility one year study; half will be randomly assigned into the proactive management group (test) and the other half will be in the standard management (control). The study will refit symptomatic daily wear soft contact lens wearers with a standard daily disposable CE marked contact lenses, and those who are proactively managed (test) will be expected to experience lesser symptoms and longer comfortable wearing time than those following a standard management routine (control).
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0245
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion