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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 range18 Years – 79 Years

SexALL

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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
✕. 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.

What they're measuring

Patient reported symptoms

Timeframe: 28 days (analysed for each treatment period)

Patient reported quality of life

Timeframe: 28 days (analysed for each treatment period)

Trial details

NCT IDNCT03140111

SponsorNHS Greater Glasgow and Clyde

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-30

Contact for this trial

Susan Clark

01698 748 832 SC@lamellar.com

View on ClinicalTrials.gov More Dry Eye Syndromes trials