LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients (NCT03140111) | Clinical Trial Compass
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LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients
12 participantsStarted 2017-10-16
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient reported symptoms
Timeframe: 28 days (analysed for each treatment period)
2
Patient reported quality of life
Timeframe: 28 days (analysed for each treatment period)
. 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
. Participants who are judged inappropriate for inclusion in the study by the CI or PI.