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.
Baylor College of Medicine
Lead sponsor
Harrow Inc
Collaborator