Not Yet RecruitingPhase 4

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

60 participantsStarted 2026-04-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. Have both of these signs of DED in the same eye at the Enrollment (baseline) 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.
✕. Unanesthetized Schirmer test score ≥ 5 and \< 15mm/5 min in at least 1 eye at the enrollment visit.
✕. A SANDE eye discomfort visual analog questionnaire score of ≥ 35 at the enrollment visit.
✕. Good general and ocular health, as determined by the investigator using medical history and ophthalmic examination.

What they're measuring

Primary Outcome

Timeframe: 60 days

Trial details

NCT IDNCT07368595

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Stephen C Pflugfelder, M.D.

713-798-4732 stevenp@bcm.edu

View on ClinicalTrials.gov More Dry Eye Disease (DED) trials