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

Starting soon · Phase 4

Conditions studied: Dry Eye Disease (DED)

In brief

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

Key facts

Study ID

NCT07368595

Run by

Baylor College of Medicine

People needed

60

Starts

2026-09-01

Expected to finish

2027-06-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Male or female, 18 years of age or older at enrollment. 2. 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. 4. 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.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Have given written informed consent prior to any study related procedures. 9. Able and willing to follow study instructions and likely to complete all required study visits as assessed by the investigator.

You may not qualify if…

• Inclusion Criteria:
• To be eligible to participate in this trial, an individual must meet all the following 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.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Have given written informed consent prior to any study related procedures.
• Able and willing to follow study instructions and likely to complete all required study visits as assessed by the investigator.
• Exclusion Criteria:
• Subjects meeting any of the following criteria at the enrollment visit will be excluded from entry into the study:
• Ophthalmic:
• History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety, such as: significant conjunctival scarring; pterygium or nodular pinguecula; conjunctivitis, or inflammation not associated with DED; clinically significant anterior blepharitis (Staphylococcal or Demodex).
• Other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation.
• History of ocular surgery within 1 year prior to the Screening visit, including punctal cautery, corneal refractive, or anterior segment surgeries (e.g., cataract surgery or any surgery creating limbal or corneal incisions).
• History of corneal transplant in one or both eyes.
• Diagnosis of recurrent, ongoing, or active ocular infection including, but not limited to herpes simplex or zoster, bacterial or fungal keratitis.
• Use of contact lenses in either eye within 90 days prior to the enrollment visit or planned use during the study.
• Punctal or intracanalicular plug present in either eyelid within 90 days prior to the enrollment visit or anticipated plug insertion or occlusion at any time during the study.
• Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Enrollment visit or any planned use during the study.
• Use of lid heating therapy (i.e., LipiFlow®, iLUX®, Thermal OneTouch, TearCare®) or Meibomian gland probing/therapeutic expression within 90 days prior to enrollment or anticipated during the study.

Full record on ClinicalTrials.gov

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