Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:14 AM
Study NCT ID:
NCT07368595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSAGCD
Brief 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
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: