Lamelleye vs Comparator for the Treatment of Dry Eye Disease

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.

Inclusion criteria

• Participant has provided written informed consent.
• Male or female Participants ≥ 18 and ≤ 79 years of age.
• 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)
• Participant must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion criteria

• Active ocular infection
• Ocular surgery within 6 months of study start date
• Current contact lens wear
• Any ophthalmologic drops within 1 week prior to enrolment that in the opinion of the CI or PI may interfere with the study outcomes.
• 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.
• 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.
• Known hypersensitivity to any of the agents used in testing such as allergies to egg or soya based products.
• Females who are or wish to become pregnant