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Dry Eye Disease (DED)Phase 4CSAGCDNCT07368595

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

A Phase 4 study testing Vevye® and Cyclosporine emulsion in people with Dry Eye Disease (DED), run by Baylor College of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease (DED)
What is being tested?
Vevye® and Cyclosporine emulsion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Sep 2026to Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 3. 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.
  • 5. A SANDE eye discomfort visual analog questionnaire score of ≥ 35 at the enrollment visit.
  • 6. Good general and ocular health, as determined by the investigator using medical history and ophthalmic examination.
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  • 7. 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.
  • 8. 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.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Use of Intense Pulsed Light (IPL) therapy on eyelids within 90 days prior to enrollment or anticipated during the study.
  • Use of artificial tears within 24 hours prior to enrollment or anticipated use during the study.
  • Use of any topical ocular cyclosporine A formulation (e.g., ocular cyclosporine [Restasis®, Cequa™, Vevye™, generics] within 1 year prior to enrollment. Use of lifitegrast [Xiidra®]), perfluorohexyloctane [Meibo™]), Tryptyr™, or any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 90 days prior to enrollment or anticipated use during the study.
  • Use of topical ocular autologous serum/plasma within 90 days prior to the enrollment or anticipated use during the study.
  • Use of any topical ocular glaucoma medication within 30 days prior to enrollment or anticipated use during the study.
  • Regular use, as defined by the investigator, of any other topical ocular medication not listed in Exclusion 11, 12, 13 or 14 within 14 days prior to the enrollment visit or anticipated use during the study (e.g., eye whitening products [Visine®, Lumify®], topical ocular antibiotics, topical ocular antihistamines, mast cell stabilizers, presbyopia correcting drops [e.g., Vuity™].
  • Use of Tyrvaya™ (varenicline solution, nasal spray 0.03 mg) within 90 days prior to the enrollment visit or anticipated use during the study.
  • Use of oral medications for the treatment of severe DED and/or Meibomian gland disease such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines or tetracycline derivatives, and oral retinoids within 30 days prior to enrollment or anticipated use during the study.
  • General/Systemic:
  • Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or antidepressants) less than 30 days prior to enrollment or a change in dosage is anticipated during the study. Note: occasional short-term use of these medications, such as systemic antihistamines will be permitted, provided that use was not within 7 days prior to enrollment. Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the enrollment visit or a change in dosage is anticipated during the study. Note: Non-ocular topically applied corticosteroids (including topical creams, nasal sprays and inhalers) will be permitted during the study, and the dose is not required to be stable.
  • Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the enrollment visit or a change in dosage is anticipated during the study.
  • Use of an investigational product or device within 30 days prior to the Screening visit.
  • At the enrollment visit, at the investigator's discretion, have uncontrolled or severe:
  • Systemic allergy
  • Rhinitis or sinusitis
  • Atopic dermatitis involving the eyelids
  • History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic). Significant is defined as any disease that, in the assessment of the Investigator, would put the safety of the subject at risk through participation, or would prevent or confound protocol-specified assessments (e.g., severe rheumatoid arthritis, severe systemic lupus erythematosus, uncontrolled immunodeficiency disease, etc.).
  • Known allergies or sensitivity to the study interventions or study diagnostic agents, including sodium fluorescein, lissamine green, etc.
  • Pregnant at enrollment, currently breastfeeding or plans to become pregnant or breastfeed during the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Stephen C Pflugfelder, M.D. contact

713-798-4732

stevenp@bcm.edu

Jenna Davis, B.S. contact

jenna.wilkins@bcm.edu

About this study

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

Read the 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.

Being tested
Vevye®, Cyclosporine emulsion
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vevye®Drug

    cyclosporine 0.1% in perfluoroalkane vehicle

  • Cyclosporine emulsionDrug

    cyclosporine 0.05% emulsion

Study groups in NCT07368595
Study groupRoleWhat they receive
Vevye®ExperimentalCyclosporine dissolved in perfluorobutylpentane (Vevye®)
Receives: Drug: Vevye®
Cyclosporine emulsionActive comparatorCyclosporine emulsion
Receives: Drug: Cyclosporine emulsion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome

    Percentage change from baseline in goblet cell density at Day 60

    Measured: 60 days

Secondary outcomes (4)

  1. Secondary Outcome 1

    Change from baseline in goblet cell density at Day 60

    Measured: 60 days

  2. Secondary Outcome 2

    Proportion of subjects with an increase in areas covered by goblet cells at Day 60

    Measured: 60 days

  3. Secondary Outcome 3

    Proportion of subjects with increase in mean goblet cell density at Day 60

    Measured: 60 days

  4. Secondary Outcome 4

    Change from baseline in goblet cell density at Days 14 and 30

    Measured: Days 14 and 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07368595
Sponsor's protocol ID
H-58336
Acronym
CSAGCD
Status last verified
Jan 2026
First submitted
20 Jan 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vevye® and Cyclosporine emulsion in people with Dry Eye Disease (DED), run by Baylor College of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephen C Pflugfelder, M.D. (713-798-4732, stevenp@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07368595.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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