LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

NCT03140111 | Unknown

• 2 other identifiers: GN16HS410001172
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye Syndromes; Primary Sjögren Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Non-invasive tear break-up time (NITBUT)

  28 days (analysed for each treatment period)

• Evaporimetry

  28 days (analysed for each treatment period)

• Interferometry

  28 days (analysed for each treatment period)

• Osmolarity

  28 days (analysed for each treatment period)

• Corneal and Conjunctival Staining

  28 days (analysed for each treatment period)

Study Arms (2)

Treatment A, followed by Treatment B

OTHER

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; Device: OPTIVE FUSION

Treatment B, followed by Treatment A

OTHER

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; Device: OPTIVE FUSION

Interventions

LAMELLEYE DEVICE

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

Also known as: CXB/1-14

Treatment A, followed by Treatment B; Treatment B, followed by Treatment A

OPTIVE FUSION DEVICE

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.

Treatment A, followed by Treatment B; Treatment B, followed by Treatment A

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Lamellar Biomedical Ltd: collaborator
• Robertson Centre for Biostatistics - University of Glasgow: collaborator
• Glasgow Caledonian University: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Monica Gupta

  NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Clark

CONTACT

01698 748 832; SC@lamellar.com

Steven Porteous

CONTACT

01698 748 832; SP@lamellar.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: October 16, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share