Lamelleye vs Comparator for the Treatment of Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

Post-approval Study to Assess Lamelleye vs Comparator for the Treatment of Dry Eye Disease in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052140
• Other study ID #: 001170
• Status: Completed
• Phase: N/A
• First received: October 11, 2016
• Last updated: August 25, 2017
• Start date: February 21, 2017
• Est. completion date: August 9, 2017

Study information

• Verified date: August 2017
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 9, 2017
• Est. primary completion date: August 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Lamelleye Dry Eye Drops
Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
• Optive 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

Locations

Country	Name	City	State
United Kingdom	Glasgow Caledonian University	Glasgow	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
Glasgow Caledonian University	Lamellar Biomedical Ltd, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive tear break-up time (outcome used to power study)	Measure of time taken from blink to breakup of tear film	14 days (analysed for each Treatment period)
Secondary	Ocular Surface Disease Index (OSDI)	12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning	14 days (analysed for each Treatment period)
Secondary	Symptom Assessment in Dry Eye (SANDE)	Two questions which each use a horizontal visual analogue technique to quantify patient symptomatology of dryness and/or irritation	14 days (analysed for each Treatment period)
Secondary	Evaporimetry	Measure of the rate of evaporation of the tear film from the surface of the eye.	14 days (analysed for each Treatment period)
Secondary	Interferometry	Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film.	14 days (analysed for each Treatment period)
Secondary	Osmolarity	Tear osmolarity is a test to determine the solute concentration of the tear film.	14 days (analysed for each Treatment period)
Secondary	Corneal and Conjunctival Staining	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	14 days (analysed for each Treatment period)