LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes, Primary Sjögren Syndrome

Intervention / Treatment
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* Device: LAMELLEYE
* Device: OPTIVE FUSION


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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) |