This goal of this clinical trial is to compare the effects of two approved cyclosporine eye drops that have different concentrations and vehicles on the number of mucus producing conjunctival goblet cells in patients with dry eye disease to learn which one causes the greatest increase.
The main questions it aims to answer are:
Does one drug cause a greater increase in goblet cells? How many weeks does it take to see the difference?
Participants will:
Use the eye drops every day for 2 months Visit the clinic once every 2 weeks for exams and tests
1. Male or female, 18 years of age or older at enrollment. 2. Have a history of DED, clinician diagnosed or patient reported, within the 6 months prior to the enrollment visit.
Total cornea fluorescein staining score ≥ 3 based on the modified National Eye Institute (NEI) grading scheme.
Total conjunctival lissamine green staining score ≥ 2 based on the modified NEI grading scheme. 4. Unanesthetized Schirmer test score ≥ 5 and < 15mm/5 min in at least 1 eye at the enrollment visit.
Male or female, 18 years of age or older at enrollment.
Have a history of DED, clinician diagnosed or patient reported, within the 6 months prior to the enrollment visit.
Total cornea fluorescein staining score ≥ 3 based on the modified National Eye Institute (NEI) grading scheme.
Total conjunctival lissamine green staining score ≥ 2 based on the modified NEI grading scheme.
Parallel
Vevye®
Drugcyclosporine 0.1% in perfluoroalkane vehicle
Cyclosporine emulsion
Drugcyclosporine 0.05% emulsion
Primary Outcome
Percentage change from baseline in goblet cell density at Day 60
Secondary Outcome 1
Change from baseline in goblet cell density at Day 60
Secondary Outcome 2
Proportion of subjects with an increase in areas covered by goblet cells at Day 60
Secondary Outcome 3
Proportion of subjects with increase in mean goblet cell density at Day 60
Secondary Outcome 4
Change from baseline in goblet cell density at Days 14 and 30
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Baylor College of Medicine
Lead sponsor
Harrow Inc
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
