LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

NHS Trust

Status: Unknown

Conditions: Primary Sjögren Syndrome; Dry Eye Syndromes

Treatments: Device: LAMELLEYE; Device: OPTIVE FUSION

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03140111

GN16HS410

001172 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Treatment A, followed by Treatment B

Other group

Description:

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.

Treatment:

Device: OPTIVE FUSION

Device: LAMELLEYE

Treatment B, followed by Treatment A

Other group

Description:

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.

Treatment:

Device: OPTIVE FUSION

Device: LAMELLEYE