LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Dry Eye Syndromes; Primary Sjögren Syndrome
• Intervention / Treatment: Device: LAMELLEYE; Device: OPTIVE FUSION

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Clark; Phone Number: 01698 748 832; Email: SC@lamellar.com
• Study Contact Backup: Name: Steven Porteous; Phone Number: 01698 748 832; Email: SP@lamellar.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be eligible for inclusion, each Participant must meet each of the following:

1. Male or female aged ≥ 18 years and ≤ 79 years at date of consent
2. Primary Sjögren's Syndrome diagnosed by a rheumatologist
3. Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy
4. 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
5. 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:

1. Females who are pregnant, planning pregnancy or breastfeeding
2. Active ocular infection or current corneal ulceration
3. Ocular surgery within 6 months of study start date
4. Current contact lens wear
5. Any prior and/or current topical ophthalmic treatments that in the opinion of the CI or PI may interfere with the study outcomes
6. 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
7. Participants with known allergies to ingredients in any of the study treatments, or fluorescein
8. Participants who are judged inappropriate for inclusion in the study by the CI or PI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Treatment A, followed by Treatment B; 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.	Device: LAMELLEYE; Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.; Other Names: CXB/1-14; Device: OPTIVE FUSION; 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.
OTHER: Treatment B, followed by Treatment A; 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.	Device: LAMELLEYE; Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.; Other Names: CXB/1-14; Device: OPTIVE FUSION; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days (analysed for each treatment period)
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.	28 days (analysed for each treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-invasive tear break-up time (NITBUT)	Measure of time taken from blink to breakup of tear film	28 days (analysed for each treatment period)
Evaporimetry	Measure of the rate of evaporation of the tear film from the surface of the eye	28 days (analysed for each treatment period)
Interferometry	Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film	28 days (analysed for each treatment period)
Osmolarity	Tear osmolarity is a test to determine the solute concentration of the tear film	28 days (analysed for each treatment period)
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	28 days (analysed for each treatment period)
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	28 days (analysed for each treatment period)

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Glasgow Caledonian University; Lamellar Biomedical Ltd; Robertson Centre for Biostatistics - University of Glasgow
• Investigators: Principal Investigator: Monica Gupta, NHS Greater Glasgow & Clyde

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 16, 2017
• Primary Completion (ANTICIPATED): March 30, 2018
• Study Completion (ANTICIPATED): March 30, 2018

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome
• Other Study ID Numbers: GN16HS410; 001172 (OTHER_GRANT: Lamellar Biomedical Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No