Back to resultsLAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients
Primary Purpose
Dry Eye Syndromes, Primary Sjögren Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LAMELLEYE
OPTIVE FUSION
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
To be eligible for inclusion, each Participant must meet each of the following:
- Male or female aged ≥ 18 years and ≤ 79 years at date of consent
- Primary Sjögren's Syndrome diagnosed by a rheumatologist
- Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy
- Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic for therapy assessment; and to comply with all procedures and follow-up visits
- Participant must have personally given written informed consent to allow anonymised data to be used in publications and presentations.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria are met:
- Females who are pregnant, planning pregnancy or breastfeeding
- Active ocular infection or current corneal ulceration
- Ocular surgery within 6 months of study start date
- Current contact lens wear
- Any prior and/or current topical ophthalmic treatments 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 prior to enrolment
- Participants with known allergies to ingredients in any of the study treatments, or fluorescein
- Participants who are judged inappropriate for inclusion in the study by the CI or PI.
Sites / Locations
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 28 days, followed by Treatment B for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION 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 28 days, followed by Treatment A for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.
Outcomes
Primary Outcome Measures
Patient reported symptoms
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
and 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
Patient reported quality of life
Impact of Dry Eye Disease on Everyday Life (IDEEL - copyright Novartis Pharma AG):
The use of this questionnaire (Treatment Satisfaction module only) will provide assessment of the impact of study treatment on patient outcomes in this study.
Secondary Outcome Measures
Non-invasive tear break-up time (NITBUT)
Measure of time taken from blink to breakup of tear film
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
Inflammatory markers
Cytokine analysis will be carried out to determine the presence and concentration of a panel of inflammatory biomarkers in the tears using a multiplex immunoassay
Full Information
NCT ID
NCT03140111
First Posted
May 2, 2017
Last Updated
September 8, 2017
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Lamellar Biomedical Ltd, Robertson Centre for Biostatistics - University of Glasgow, Glasgow Caledonian University
1. Study Identification
Unique Protocol Identification Number
NCT03140111
Brief Title
LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients
Official Title
Post-approval Study to Assess the Effectiveness of LAMELLEYE vs Comparator for the Treatment of Dry Eye Symptoms in Patients With Primary Sjögren's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2017 (Anticipated)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
March 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Lamellar Biomedical Ltd, Robertson Centre for Biostatistics - University of Glasgow, Glasgow Caledonian University
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 pilot study to investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary Sjögren's Syndrome.
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.
The study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patient's disease specific quality of life, symptoms and adverse events, and satisfaction with treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Primary Sjögren Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
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 28 days, followed by Treatment B for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION 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 28 days, followed by Treatment A for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION 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
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 FUSION
Intervention Description
Multi-dose sterile solution which contains sodium hyaluronate 0.1%, sodium carboxymethylcellulose 0.5%, glycerine 0.9%, erythritol, boric acid, sodium citrate dihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and is preserved with PURITE® 0.01% which breaks down into natural tear components on the eye.
Primary Outcome Measure Information:
Title
Patient reported symptoms
Description
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
and 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
Time Frame
28 days (analysed for each treatment period)
Title
Patient reported quality of life
Description
Impact of Dry Eye Disease on Everyday Life (IDEEL - copyright Novartis Pharma AG):
The use of this questionnaire (Treatment Satisfaction module only) will provide assessment of the impact of study treatment on patient outcomes in this study.
Time Frame
28 days (analysed for each treatment period)
Secondary Outcome Measure Information:
Title
Non-invasive tear break-up time (NITBUT)
Description
Measure of time taken from blink to breakup of tear film
Time Frame
28 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
28 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
28 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
28 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
28 days (analysed for each treatment period)
Title
Inflammatory markers
Description
Cytokine analysis will be carried out to determine the presence and concentration of a panel of inflammatory biomarkers in the tears using a multiplex immunoassay
Time Frame
28 days (analysed for each treatment period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible for inclusion, each Participant must meet each of the following:
Male or female aged ≥ 18 years and ≤ 79 years at date of consent
Primary Sjögren's Syndrome diagnosed by a rheumatologist
Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy
Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic for therapy assessment; and to comply with all procedures and follow-up visits
Participant must have personally given written informed consent to allow anonymised data to be used in publications and presentations.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria are met:
Females who are pregnant, planning pregnancy or breastfeeding
Active ocular infection or current corneal ulceration
Ocular surgery within 6 months of study start date
Current contact lens wear
Any prior and/or current topical ophthalmic treatments 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 prior to enrolment
Participants with known allergies to ingredients in any of the study treatments, or fluorescein
Participants who are judged inappropriate for inclusion in the study by the CI or PI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Clark
Phone
01698 748 832
Email
SC@lamellar.com
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Porteous
Phone
01698 748 832
Email
SP@lamellar.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Gupta
Organizational Affiliation
NHS Greater Glasgow & Clyde
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients
We'll reach out to this number within 24 hrs