THEIA - V01
Research type
Research Study
Full title
A clinical trial to investigate the safety and clinical performance of Hydroxypropyl-Beta-Cyclodextrin 10% w/v Eye Drops in the treatment of dry eye disease.
IRAS ID
249742
Contact name
Sobha Sivaprasad
Contact email
Sponsor organisation
Warneford Healthcare Limited
ISRCTN Number
ISRCTN10063734
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Dry eye disease or dry eye syndrome is a multifactorial and complex disorder of the tears and ocular surface which occurs when the quantity or quality of tears fails to maintain adequate lubrication of surface of the eye. Dry eye incidence increases with age and prevalence ranges from 5% to 35% of the adult population depending on the definition of dry eye utilised. Dry eye is a frequently encountered ocular morbidity with 25% of patients who visit ophthalmic clinics report symptoms of dry eye. There are multiple therapeutic options available for dry eye, many of which aim to help lubricate the ocular surface and hence reduce the symptoms of dry eye, however not all patients respond favourably to the prescribed treatments.
Hydroxypropyl-Beta-Cyclodextrin is a soluble, benign, safe and well characterised cyclodextrin that is accepted as an approved excipient of drug formulations, including eye drops, across Europe. Current research suggests Hydroxypropyl-Beta-Cyclodextrin is a suitable molecule for treating the symptoms of dry eye, however due to gaps in the literature this hypothesis remains unconfirmed.This clinical investigation is aiming to establish the safety and performance characteristics of the medical device Hydroxypropyl-Beta-Cyclodextrin 10% w/v Eye Drops (preservative free), indicated for the relief of dry eye sensations.
The development of Hydroxypropyl-Beta-Cyclodextrin 10% w/v as a novel dry eye drop may provide a safe, efficacious and cost-effective alternative treatment for patients suffering from dry eye.
The study involves application of one drop of Hydroxypropyl-Beta-Cyclodextrin 10% w/v eye drops to each eye two or three times daily, or as required over the course of the six months. Patients will be requested to complete a daily diary, a questionnaire and to visit to the centres at 1, 3 and 6 months where information is collected including but not limited to Schirmer's test, Tear Film Break-up Time and OCT scan.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/0623
Date of REC Opinion
24 May 2019
REC opinion
Further Information Favourable Opinion