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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03140111
Other study ID # GN16HS410
Secondary ID 001172
Status Not yet recruiting
Phase N/A
First received May 2, 2017
Last updated September 8, 2017
Start date October 16, 2017
Est. completion date March 30, 2018

Study information

Verified date September 2017
Source NHS Greater Glasgow and Clyde
Contact Susan Clark
Phone 01698 748 832
Email SC@lamellar.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date March 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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 Design


Intervention

Device:
LAMELLEYE
Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
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.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde Glasgow Caledonian University, Lamellar Biomedical Ltd, Robertson Centre for Biostatistics - University of Glasgow

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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)
Secondary Evaporimetry Measure of the rate of evaporation of the tear film from the surface of the eye 28 days (analysed for each treatment period)
Secondary 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)
Secondary Osmolarity Tear osmolarity is a test to determine the solute concentration of the tear film 28 days (analysed for each treatment period)
Secondary 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)
Secondary 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)
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