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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

NCT07368595 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-26

No results posted yet for this study

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

Conditions

  • Dry Eye Disease (DED)

Interventions

DRUG

Vevye®

cyclosporine 0.1% in perfluoroalkane vehicle

DRUG

Cyclosporine emulsion

cyclosporine 0.05% emulsion

Sponsors & Collaborators

  • Harrow Inc

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Stephen C Pflugfelder, M.D. · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-03-31
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07368595 on ClinicalTrials.gov