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Device

Treatment A, followed by Treatment B for Dry Eye Syndrome

N/A
Waitlist Available
Led By Monica Gupta
Research Sponsored by NHS Greater Glasgow and Clyde
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days (analysed for each treatment period)
Awards & highlights

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.

Eligible Conditions
  • Dry Eye Syndrome
  • Sjögren's Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days (analysed for each treatment period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days (analysed for each treatment period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient reported quality of life
Patient reported symptoms
Secondary study objectives
Corneal and Conjunctival Staining
Evaporimetry
Inflammatory markers
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment B, followed by Treatment AExperimental Treatment2 Interventions
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 II: Treatment A, followed by Treatment BExperimental Treatment2 Interventions
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.

Who is running the clinical trial?

Glasgow Caledonian UniversityOTHER
60 Previous Clinical Trials
12,914 Total Patients Enrolled
Lamellar Biomedical LtdIndustry Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
NHS Greater Glasgow and ClydeLead Sponsor
283 Previous Clinical Trials
318,298 Total Patients Enrolled
~2 spots leftby Sep 2025
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