Lamelleye vs Comparator for the Treatment of Dry Eye Disease

Glasgow Caledonian University

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: Optive Plus; Device: Lamelleye Dry Eye Drops

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03052140

001170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Treatment A, followed by Treatment B

Other group

Description:

Treatment group that will receive Treatment A for 14 days, followed by Treatment B for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.

Treatment:

Device: Optive Plus

Device: Lamelleye Dry Eye Drops

Treatment B, followed by Treatment A

Other group

Description:

Treatment group that will receive Treatment B for 14 days, followed by Treatment A for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.

Treatment:

Device: Optive Plus

Device: Lamelleye Dry Eye Drops