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 | Not Yet Recruiting Phase 4

• 1 other identifier: H-58336
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Percentage change from baseline in goblet cell density at Day 60

  60 days

Secondary Outcomes (4)

• Secondary Outcome 1

  60 days

• Secondary Outcome 2

  60 days

• Secondary Outcome 3

  60 days

• Secondary Outcome 4

  Days 14 and 30

Study Arms (2)

Vevye®

EXPERIMENTAL

Cyclosporine dissolved in perfluorobutylpentane (Vevye®)

Drug: Vevye®

Cyclosporine emulsion

ACTIVE COMPARATOR

Cyclosporine emulsion

Drug: Cyclosporine emulsion

Interventions

Vevye® DRUG

cyclosporine 0.1% in perfluoroalkane vehicle

Vevye®

Cyclosporine emulsion DRUG

cyclosporine 0.05% emulsion

Cyclosporine emulsion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:

• 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.
• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Harrow Inc: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Stephen C Pflugfelder, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen C Pflugfelder, M.D.

CONTACT

713-798-4732; stevenp@bcm.edu

Jenna Davis, B.S.

CONTACT

jenna.wilkins@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Laboratory perfoming goblet cell analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 26, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01