Dry Eye Syndromes, Primary Sjögren Syndrome
Conditions
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.
Interventions
DEVICELAMELLEYE
Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
DEVICEOPTIVE 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.
Sponsors
Lamellar Biomedical Ltd
Robertson Centre for Biostatistics - University of Glasgow
Glasgow Caledonian University
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported symptoms | 28 days (analysed for each treatment period) | 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 | 28 days (analysed for each treatment period) | 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
| Measure | Time frame | Description |
|---|---|---|
| Interferometry | 28 days (analysed for each treatment period) | Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film |
| Osmolarity | 28 days (analysed for each treatment period) | Tear osmolarity is a test to determine the solute concentration of the tear film |
| Non-invasive tear break-up time (NITBUT) | 28 days (analysed for each treatment period) | Measure of time taken from blink to breakup of tear film |
| Inflammatory markers | 28 days (analysed for each treatment period) | 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 |
| Corneal and Conjunctival Staining | 28 days (analysed for each treatment period) | 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 |
| Evaporimetry | 28 days (analysed for each treatment period) | Measure of the rate of evaporation of the tear film from the surface of the eye |
Contacts
Primary ContactSusan Clark
Backup ContactSteven Porteous
Outcome results
None listed