LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2018-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Syndromes Primary Sjögren Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A, followed by Treatment B

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.

Group Type OTHER

LAMELLEYE

Intervention Type DEVICE

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

OPTIVE FUSION

Intervention Type 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 B, followed by Treatment A

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.

Group Type OTHER

LAMELLEYE

Intervention Type DEVICE

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

OPTIVE FUSION

Intervention Type 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.

Interventions

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LAMELLEYE

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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CXB/1-14

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No