Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07368595
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
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:
NCT07368595
Study Brief:
Protocol Section:
NCT07368595