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New eye ointment aimed at soothing chronic eyelid inflammation

NCT ID NCT06400511

Disease control Sponsor: Famy Life Sciences, a Viatris Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a medicated ointment called pimecrolimus 0.3% for people with blepharitis, a condition that causes red, irritated eyelids. The trial planned to include 477 participants aged 2 and older, applying the ointment twice daily to the eyelid margins. The main goal was to see if it could clear eyelid debris and reduce discomfort. However, the study was terminated early, so final results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pimecrolimus 0.3% ophthalmic ointment
What this could lead to
If successful, this could provide a new treatment option for blepharitis, reducing eyelid debris and discomfort.
What could go wrong
The study was terminated, so results are incomplete. It is unclear if the ointment works better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

477 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects aged ≥ 2 years of age or older at Visit 1, with a diagnosis of blepharitis confirmed by the investigator. 2. Subjects under 18 must able to be examined at the slit lamp (handheld) without systemic anesthesia. 3. A self-reported history of at least 1 previous episode of blepharitis. 4. Adult subjects have provided verbal and written informed consent. For subjects under 16 years of age, a parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form (or equivalent, if applicable), approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Whenever practical and appropriate per local requirements, a child's assent should also be sought before inclusion into the study. 5. Subjects who have not responded adequately to lid hygiene in the past (self-reported). 6. Have a Corrected Distance Visual Acuity (CDVA) greater than or equal to 0.7 logMar in each eye, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Subjects may be refracted if needed. 7. Subjects must be able to comply with the requirements of the protocol including the ability to self-administer or receive topical treatment twice a day to their eyelid margins. 8. Be literate and able to complete questionnaires independently, or in the case of pediatric patients, can comprehend the questionnaires with the help of a parent/guardian or interviewer. 9. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Visit 1 and must be willing to use an adequate method of contraception throughout the study and 30 days from the last application of the study treatment. Exclusion Criteria: 1. Subjects who have received a COVID vaccination or recovered from COVID-19 symptoms less than 1 week prior to baseline visit. 2. Subjects with a history of, or active herpetic or neurotrophic keratitis. 3. Subjects who, in the opinion of the investigator, have abnormal eyelid anatomy (other than due to blepharitis) that might adversely affect clinical signs and symptoms, including but not limited to lagophthalmos, malposition of the eyelid or tumor(s) of the eyelid or eyelid margin. 4. Subjects who have received other treatments for blepharitis within 30 days of Visit 1. 5. Subjects with known hypersensitivity to study medications, or to any diagnostic agents to be used in the study. 6. Subjects who are currently enrolled in an investigational drug or device study or have used an investigational drug or device within the 30 days prior to the baseline visit and during the treatment period. 7. Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol.

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Conditions

The condition(s) this trial relates to.

blepharitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blepharitis

Contacts and locations

Locations

  • Clinical Investigative Site

    Pheonix, Arizona, 85032, United States

  • Clinical Investigator Site

    Garden Grove, California, 92843, United States

  • Clinical Investigator Site

    Glendale, California, 91204, United States

  • Clinical Investigator Site

    Inglewood, California, 90301, United States

  • Clinical Investigator Site

    Newport Beach, California, 92663, United States

  • Clinical Investigator Site

    Petaluma, California, 94954, United States

  • Clinical Investigator Site

    Rancho Cordova, California, 95670, United States

  • Clinical Investigator Site

    Aurora, Colorado, 80045, United States

  • Clinical Investigator Site

    Crystal River, Florida, 34429, United States

  • Clinical Investigator Site

    Largo, Florida, 33773, United States

  • Clinical Investigator Site

    Tampa, Florida, 33603, United States

  • Clinical Investigator Site

    Atlanta, Georgia, 30339, United States

  • Clinical Investigator Site

    Morrow, Georgia, 30260, United States

  • Clinical Investigator Site

    Pittsburg, Kansas, 66762, United States

  • Clinical Investigator Site

    Louisville, Kentucky, 40206, United States

  • Clinical Investigator Site

    Havre de Grace, Maryland, 21078, United States

  • Clinical Investigator Site

    Medina, Minnesota, 55340, United States

  • Clinical Investigator Site

    Kansas City, Missouri, 64154, United States

  • Clinical Investigator Site

    Washington, Missouri, 63090, United States

  • Clinical Investigator Site

    Garner, North Carolina, 27529, United States

  • Clinical Investigator Site

    Cincinnati, Ohio, 45242, United States

  • Clinical Investigator Site

    Cranberry Township, Pennsylvania, 16066, United States

  • Clinical Investigator Site

    Smyrna, Tennessee, 37167, United States

  • Clinical Investigator Site

    Austin, Texas, 78731, United States

  • Clinical Investigator Site

    Lakeway, Texas, 78738, United States

  • Clinical Investigator Site

    San Antonio, Texas, 78229, United States

  • Clinical Investigator Site

    Clinton, Utah, 84015, United States

  • Clinical Investigator Site

    Lynchburg, Virginia, 24502, United States

  • Investigative Site

    St Louis, Missouri, 63131, United States

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