Back to resultsLamelleye vs Comparator for the Treatment of Dry Eye Disease
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lamelleye Dry Eye Drops
Optive Plus
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
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
Sites / Locations
- Glasgow Caledonian University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Treatment A, followed by Treatment B
Treatment B, followed by Treatment A
Arm 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 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.
Outcomes
Primary Outcome Measures
Non-invasive tear break-up time (outcome used to power study)
Measure of time taken from blink to breakup of tear film
Secondary Outcome Measures
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
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
Evaporimetry
Measure of the rate of evaporation of the tear film from the surface of the eye.
Interferometry
Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film.
Osmolarity
Tear osmolarity is a test to determine the solute concentration of the tear film.
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
Full Information
NCT ID
NCT03052140
First Posted
October 11, 2016
Last Updated
August 25, 2017
Sponsor
Glasgow Caledonian University
Collaborators
Lamellar Biomedical Ltd, University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT03052140
Brief Title
Lamelleye vs Comparator for the Treatment of Dry Eye Disease
Official Title
Post-approval Study to Assess Lamelleye vs Comparator for the Treatment of Dry Eye Disease in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
August 9, 2017 (Actual)
Study Completion Date
August 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glasgow Caledonian University
Collaborators
Lamellar Biomedical Ltd, University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A, followed by Treatment B
Arm Type
Other
Arm 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.
Arm Title
Treatment B, followed by Treatment A
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Lamelleye Dry Eye Drops
Other Intervention Name(s)
CXB/1-14
Intervention Description
Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
Intervention Type
Device
Intervention Name(s)
Optive Plus
Intervention Description
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
Primary Outcome Measure Information:
Title
Non-invasive tear break-up time (outcome used to power study)
Description
Measure of time taken from blink to breakup of tear film
Time Frame
14 days (analysed for each Treatment period)
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI)
Description
12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning
Time Frame
14 days (analysed for each Treatment period)
Title
Symptom Assessment in Dry Eye (SANDE)
Description
Two questions which each use a horizontal visual analogue technique to quantify patient symptomatology of dryness and/or irritation
Time Frame
14 days (analysed for each Treatment period)
Title
Evaporimetry
Description
Measure of the rate of evaporation of the tear film from the surface of the eye.
Time Frame
14 days (analysed for each Treatment period)
Title
Interferometry
Description
Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film.
Time Frame
14 days (analysed for each Treatment period)
Title
Osmolarity
Description
Tear osmolarity is a test to determine the solute concentration of the tear film.
Time Frame
14 days (analysed for each Treatment period)
Title
Corneal and Conjunctival Staining
Description
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
Time Frame
14 days (analysed for each Treatment period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Pearce
Organizational Affiliation
Glasgow Caledonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Caledonian University
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0BA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be made available
Learn more about this trial
Lamelleye vs Comparator for the Treatment of Dry Eye Disease
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