NCT07368595

Comparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1% Dissolved in Perfluorobutylpentane (Vevye®) or Generic 0.05% Cyclosporine Emulsion for 8 Weeks

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Sixty participants with dry eye will be randomized to receive either cyclosporine 0.1% dissolved in perfluorobutylpentane (Vevye®) or 0.05% cyclosporine emulsion (generic Restasis®) to instill in their eyes twice a day for 60 days. The number of mucus producing goblet cells will be measured in the conjunctiva in both eyes by impression cytology. The percentage change in goblet cell number from baseline (before treatment ) at day 60 is the primary endpoint. Treatment groups will also be compared at days 14 and 30.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	Vevye®	cyclosporine 0.1% in perfluoroalkane vehicle
DRUG	Cyclosporine emulsion	cyclosporine 0.05% emulsion

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-31
• Completion: 2027-06-01
• First posted: 2026-01-26
• Last updated: 2026-01-26