LAMELLEYE for the treatment of dry eye symptoms in pSS patients
Research type
Research Study
Full 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
IRAS ID
202738
Contact name
Monica Gupta
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Patients with primary Sjogren's Syndrome (pSS) can suffer from dry eyes. Some patients do not find any of the current available treatments for dry eye provide any relief from their symptoms.
LAMELLEYE is a new eye drop for the treatment of dry eye. LAMELLEYE is intended to moisturise and lubricate the surface of the eye, and provide relief from the dry, itchy feeling that patients with dry eye often experience. Lamelleye is approved (CE-marked) for use in patients with symptoms of dry eye, regardless of the cause.
This research study is a randomised, single-blind, single-centre, 2-way crossover pilot study. Patients will be identified by an expert in pSS at Gartnavel General Hospital, and will attend study visits at Glasgow Caledonian University (GCU) department of Vision Sciences with experts in the assessment and treatment of dry eye. The study will include 12 adult patients with pSS.
Primary objective:
To investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with pSS.
Secondary objectives:
• To assess the effect of LAMELLEYE on various different measures of the tear film; and
• To assess how well LAMELLEYE works in comparison with another CE-marked eye drop (OPTIVE FUSION™).
There will be a total of 6 visits, including a follow-up call 1-2 weeks after the last dose of study treatment. At each visit to GCU, patients will be asked about their medication and dry eye symptoms, and will undergo tests that will assess how bad their dry eyes are.
Taking part in the study will last for a minimum of 11 weeks (maximum 18 weeks), which includes a run-in period of 1-3 weeks using CELLUVISC™ eye drops; 4-5 weeks of using each of the study treatments; and a washout period of 1-3 weeks between study treatments using CELLUVISC™
REC name
West of Scotland REC 1
REC reference
17/WS/0118
Date of REC Opinion
1 Sep 2017
REC opinion
Further Information Favourable Opinion