Dry Eye Disease Eye Diseases Other disorders of lacrimal gland
Conditions
Interventions
The study is a single arm design, therefore randomisation is not applicable.
All participants will be treated with the Hydroxypropyl-Beta-Cyclodextrin 10% w/v Eye Drops, with 1 drop ad
Sponsors
Warneford Healthcare Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 50 years of age. 2. Mild to moderate dry eye. 3. Life expectancy of more than 6 months’ (length of study). 4. Ability to return for study visits.
Exclusion criteria
Exclusion criteria: 1. Current smoker. 2. Known to suffer from an allergy or hypersensitivity to any of the components within the medical device. 3. Taking any other eye drops for dry eye. 4. Taking any other eye drops containing cyclodextrin. 5. Has used contact lenses within the last 4-7 days. 6. Has dry eye secondary to eyelid malposition, corneal dystrophy, ocular neoplasia, filamentous keratitis, corneal neovascularisation or orbital radiotherapy, or a history of ocular disease including traumatism, infection, inflammation, allergy, or herpes within the last 3 months. 7. History of inflammatory corneal ulcer or uveitis within the last 12 months. 8. Has allergic rhinitis that is current or susceptible to reactivation during the study 9. Has had cataract or corneal surgery in the last 12 months. 10. Currently participating in any other clinical trial or has participated in another clinical trial within 3 months prior to the screening/baseline visit. 11. Not physically able to perform study procedures. 12. History of drug/alcohol abuse, mental dysfunction or other factors limiting their ability to cooperate fully. 13. Has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety of HPBCD treatment will be assessed by: 1.1. Recording symptoms and adverse events during each clinical follow up. 1.2. A full ocular exam with Optical Coherence Tomography (OCT) at each clinical follow up. 2. Clinical performance outcome will be measured using patient questionnaire answers regarding a change in baseline for dry eye symptoms at each clinical follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life will be measured using patient questionnaire answers at each clinical follow up. 2. Symptoms of dry eye disease will be measured using: 2.1. Tear film break-up time (TBUT) at each clinical follow up. 2.2. Schirmer’s test at each clinical follow up. 3. Ease of use of the device (in line with the instructions for use) will be measured using patient questionnaire answers at each clinical follow up. | — |
Countries
United Kingdom
Contacts
Public ContactStephanie Tweed
Outcome results
None listed