Lamelleye vs Comparator for the Treatment of Dry Eye Disease

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Lamelleye Dry Eye Drops; Device: Optive Plus

• Registration Number: NCT03052140
• Lead Sponsor: Glasgow Caledonian University

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.

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Study Start: 2017-02-21
• Status Verified: 2017-08
• Primary Completion: 2017-08-09
• Study Completion: 2017-08-09
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A, followed by Treatment B	Lamelleye Dry Eye Drops	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 A, followed by Treatment B	Optive Plus	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 B, followed by Treatment A	Lamelleye Dry Eye Drops	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 B, followed by Treatment A	Optive Plus	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.
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

Trial Locations

Locations (1)

Glasgow Caledonian University; 🇬🇧 Glasgow, Scotland, United Kingdom