LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

Dry Eye Syndromes Clinical Trial

Official title:

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

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
• 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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Primary Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

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)