Lamelleye vs Comparator for the Treatment of Dry Eye Disease

NCT03052140 | Completed

• 1 other identifier: 001170
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Ocular Surface Disease Index (OSDI)

  14 days (analysed for each Treatment period)

• Symptom Assessment in Dry Eye (SANDE)

  14 days (analysed for each Treatment period)

• Evaporimetry

  14 days (analysed for each Treatment period)

• Interferometry

  14 days (analysed for each Treatment period)

• Osmolarity

  14 days (analysed for each Treatment period)

Study Arms (2)

Treatment A, followed by Treatment B

OTHER

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.

Device: Lamelleye Dry Eye Drops; Device: Optive Plus

Treatment B, followed by Treatment A

OTHER

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.

Device: Lamelleye Dry Eye Drops; Device: Optive Plus

Interventions

Lamelleye Dry Eye Drops DEVICE

Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.

Also known as: CXB/1-14

Treatment A, followed by Treatment B; Treatment B, followed by Treatment A

Optive Plus DEVICE

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

Treatment A, followed by Treatment B; Treatment B, followed by Treatment A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• Lamellar Biomedical Ltd: collaborator
• University of Glasgow: collaborator

Study Sites (1)

Glasgow Caledonian University

Glasgow, Scotland, G4 0BA, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ian Pearce

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: February 14, 2017
• Study Start: February 21, 2017
• Primary Completion: August 9, 2017
• Study Completion: August 9, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)