Clinical trial NCT03052140: Lamelleye vs Comparator for the Treatment of Dry Eye Disease
Official title: Post-approval Study to Assess Lamelleye vs Comparator for the Treatment of Dry Eye Disease in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: Lamellar Biomedical Ltd
name: University of Glasgow
First posted: 2017-02-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-invasive tear break-up time (outcome used to power study)
timeFrame: 14 days (analysed for each Treatment period)
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 14 days (analysed for each Treatment period)
measure: Symptom Assessment in Dry Eye (SANDE)
timeFrame: 14 days (analysed for each Treatment period)
measure: Evaporimetry
timeFrame: 14 days (analysed for each Treatment period)
measure: Interferometry
timeFrame: 14 days (analysed for each Treatment period)
measure: Osmolarity
timeFrame: 14 days (analysed for each Treatment period)
measure: Corneal and Conjunctival Staining
timeFrame: 14 days (analysed for each Treatment period)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Scotland
Study officials:
affiliation: Glasgow Caledonian University
name: Ian Pearce
role: PRINCIPAL_INVESTIGATOR
References: