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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
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.
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
Time frame: 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.
Time frame: 28 days (analysed for each treatment period)
Non-invasive tear break-up time (NITBUT)
Measure of time taken from blink to breakup of tear film
Time frame: 28 days (analysed for each treatment period)
Evaporimetry
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)
Interferometry
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)
Osmolarity
Tear osmolarity is a test to determine the solute concentration of the tear film
Time frame: 28 days (analysed for each treatment period)
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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
Time frame: 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
Time frame: 28 days (analysed for each treatment period)