Evaluation of Rexon-Eye Efficacy for Dry Eye Subjects
Research type
Research Study
Full title
Evaluation of Rexon-Eye Efficacy in Symptomatic Contact Lens Wearers and Dry Eye Sufferers.
IRAS ID
241614
Contact name
Kishan Patel
Contact email
Sponsor organisation
CooperVision, Inc.
Duration of Study in the UK
0 years, 6 months, 20 days
Research summary
A number of instruments have been developed to offer in-office dry eye treatment, which application can extend to treating contact lens discomfort. A new device, Rexon-Eye has received CE marking to treat both evaporative and aqueous deficient dry eyes. The technology is based upon quantum molecular resonance (QMS). The device produces low power, high frequency current delivered through an eye mask over closed eyes to increase cellular regeneration, hence reactivating the tear system. The claim is that QMS increases cellular regeneration and is therefore beneficial in treating ocular tissue anomalies in dry eye subjects by stimulating both the tear gland that produces aqueous tears and the mucin producing goblet cells. The purpose of this study is to measure the effect of using CE marked Rexon-Eye device for dry eye treatment on contact lens wearers with dry eye symptoms and dry eye sufferers who do not wear contact lenses. The effect on (i) symptomatology, (ii) ocular tissue anomalies and (iii) tear volume will be evaluated. Fifty four adults will be enrolled; 30 subjects will be existing daily disposable contact lens wearers with discomfort/dry eye symptoms and 24 subjects will be dry eye sufferers who do not wear contact lenses. Subjects will be randomised to the active treatment group (test) or control (output set at 0) in a 2 to 1 ratio. The study will involve six study visits over approximately a four-month period. There will be baseline/enrollment visit, 4 weekly 20-minute treatment sessions with the device and a 3 month follow up visit. The treatment will be administered at the study site only. The participant and investigator will be masked.\n\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0026
Date of REC Opinion
14 Feb 2018
REC opinion
Further Information Favourable Opinion