Dry Eye Syndromes
Conditions
Brief summary
Single-blind, randomised, single centre, 2-way crossover study to collect post-market clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.
Detailed description
The study is a 2-way crossover design comprising 2 treatments: the CE-marked Lamelleye dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order. This study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patients' disease specific quality of life, symptoms and adverse events.
Interventions
DEVICELamelleye Dry Eye Drops
Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
DEVICEOptive Plus
Multi-dose sterile solution which contains sodium carboxymethylcellulose, glycerine, Castor Oil, Polysorbate 80, levocarnitine, and erythritol, preserved with PURITE® which breaks down into natural tear components in the eye
Sponsors
Lamellar Biomedical Ltd
University of Glasgow
Glasgow Caledonian University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant has provided written informed consent. 2. Male or female Participants ≥ 18 and ≤ 79 years of age. 3. Participant has dry eye disease as diagnosed from positive responses to Non-invasive tear break-up time (NITBUT) (≤10 seconds); Schirmer test (≤10mm in 5 minutes); and patient symptoms (\>2 symptoms using the McMonnies Dry Eye Questionnaire) 4. Participant must understand and be able, willing and likely to fully comply with study procedures and restrictions.
Exclusion criteria
1. Active ocular infection 2. Ocular surgery within 6 months of study start date 3. Current contact lens wear 4. Any ophthalmologic drops within 1 week prior to enrolment that in the opinion of the CI or PI may interfere with the study outcomes. 5. Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, anticholinergics, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial visit. 6. Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1. 7. Known hypersensitivity to any of the agents used in testing such as allergies to egg or soya based products. 8. Females who are or wish to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive tear break-up time (outcome used to power study) | 14 days (analysed for each Treatment period) | Measure of time taken from blink to breakup of tear film |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Assessment in Dry Eye (SANDE) | 14 days (analysed for each Treatment period) | Two questions which each use a horizontal visual analogue technique to quantify patient symptomatology of dryness and/or irritation |
| Evaporimetry | 14 days (analysed for each Treatment period) | Measure of the rate of evaporation of the tear film from the surface of the eye. |
| Ocular Surface Disease Index (OSDI) | 14 days (analysed for each Treatment period) | 12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning |
| Osmolarity | 14 days (analysed for each Treatment period) | Tear osmolarity is a test to determine the solute concentration of the tear film. |
| Corneal and Conjunctival Staining | 14 days (analysed for each Treatment period) | Corneal and conjunctival damage due to dry eye can be measured by staining the surface of the eye with fluorescein and examining under a lamp with a cobalt blue filter |
| Interferometry | 14 days (analysed for each Treatment period) | Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film. |
Countries
United Kingdom
Outcome results
None listed