Crossover Evaluation of Eye Drops in Symptomatic Lens Wearers (Part 1)
Research type
Research Study
Full title
Crossover Evaluation Of Clinitas Soothe® Eye Drops In Symptomatic Soft Contact Lens Wearers (Part 1)
IRAS ID
222661
Contact name
Nancy Keir
Contact email
Sponsor organisation
CooperVision Inc,
Duration of Study in the UK
0 years, 0 months, 15 days
Research summary
The purpose of this study is to assess whether comfort improves with the application of lubricating drops in contact lens wearers who experience symptoms of dryness.
This will involve a 10-15 subject, contact lens study involving two types of lubricating eyedrop (Clinitas and Minims saline) and will compare three different eyedrop regimens, i.e. varying numbers of drops applied at varying time of day. After a baseline screening visit, participants will wear their own brand of contact lenses in conjunction with each of the two eyedrops on three different treatment days separated by a minimum of one day. One type of drop will be used in one eye and the other in the fellow eye.
Participants will be existing soft lens wearers recruited on the basis of having healthy eyes, apart from needing a focussing correction and experiencing symptoms of dryness or discomfort. Participants will be screened for being symptomatic contact lens wearers on the basis of i) having a comfortable wearing time 2 hours less than their typical wearing time or ii) experiencing symptoms of late-day dryness. Only those deemed symptomatic will be dispensed lenses in the study.
This study will take place at one single clinic site, located at Visioncare Research Ltd in Farnham, Surrey, UK. The study is expected to last between 4-40 days per subject, with an approximate one month enrolment window to enrol 10-15 subjects.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0094
Date of REC Opinion
31 Mar 2017
REC opinion
Favourable Opinion