Lamelleye vs Comparator for the Treatment of Dry Eye Disease

NCT ID: NCT03052140

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2017-08-09

Brief Summary

Single-blind, randomised, single centre, 2-way crossover study to collect post-market clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.

Detailed 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.

This study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patients' disease specific quality of life, symptoms and adverse events.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment A, followed by Treatment B

Treatment group that will receive Treatment A for 14 days, followed by Treatment B for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.

Group Type: OTHER

Lamelleye Dry Eye Drops

Intervention Type: DEVICE

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

Optive Plus

Intervention Type: DEVICE

Multi-dose sterile solution which contains sodium carboxymethylcellulose, glycerine, Castor Oil, Polysorbate 80, levocarnitine, and erythritol, preserved with PURITE® which breaks down into natural tear components in the eye

Treatment B, followed by Treatment A

Treatment group that will receive Treatment B for 14 days, followed by Treatment A for 14 days. There will be a minimum 7 day washout between Treatments. Lamelleye Dry Eye Drops and Optive Plus will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day.

Group Type: OTHER

Lamelleye Dry Eye Drops

Intervention Type: DEVICE

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

Optive Plus

Intervention Type: DEVICE

Multi-dose sterile solution which contains sodium carboxymethylcellulose, glycerine, Castor Oil, Polysorbate 80, levocarnitine, and erythritol, preserved with PURITE® which breaks down into natural tear components in the eye

Interventions

Lamelleye Dry Eye Drops

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

Intervention Type: DEVICE

Optive Plus

Multi-dose sterile solution which contains sodium carboxymethylcellulose, glycerine, Castor Oil, Polysorbate 80, levocarnitine, and erythritol, preserved with PURITE® which breaks down into natural tear components in the eye

Intervention Type: DEVICE

Other Intervention Names

CXB/1-14

Eligibility Criteria

Inclusion Criteria

1. Participant has provided written informed consent.

2. Male or female Participants ≥ 18 and ≤ 79 years of age.

3. Participant has dry eye disease as diagnosed from positive responses to Non-invasive tear break-up time (NITBUT) (≤10 seconds); Schirmer test (≤10mm in 5 minutes); and patient symptoms (>2 symptoms using the McMonnies Dry Eye Questionnaire)

4. Participant must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria

1. Active ocular infection

2. Ocular surgery within 6 months of study start date

3. Current contact lens wear

4. Any ophthalmologic drops within 1 week prior to enrolment that in the opinion of the CI or PI may interfere with the study outcomes.

5. 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 of initial visit.

6. Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1.

7. Known hypersensitivity to any of the agents used in testing such as allergies to egg or soya based products.

8. Females who are or wish to become pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lamellar Biomedical Ltd

INDUSTRY

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: collaborator

Glasgow Caledonian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Pearce

Role: PRINCIPAL_INVESTIGATOR

Glasgow Caledonian University

Locations

Glasgow Caledonian University

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

Other Identifiers

001170

Identifier Type: -

Identifier Source: org_study_id