A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Blepharitis

In brief

The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.

Key facts

Study ID

NCT06400511

Run by

Famy Life Sciences, a Viatris Company

People needed

477

Starts

2024-04-22

Expected to finish

2025-10-15

Last updated by the study team

2026-01-07

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged ≥ 2 years of age or older at Visit 1, with a diagnosis of blepharitis confirmed by the investigator.
• Subjects under 18 must able to be examined at the slit lamp (handheld) without systemic anesthesia.
• A self-reported history of at least 1 previous episode of blepharitis.
• 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.
• Subjects who have not responded adequately to lid hygiene in the past (self-reported).
• 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.
• 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.
• 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.
• 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.

You may not qualify if…

• Subjects who have received a COVID vaccination or recovered from COVID-19 symptoms less than 1 week prior to baseline visit.
• Subjects with a history of, or active herpetic or neurotrophic keratitis.
• 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.
• Subjects who have received other treatments for blepharitis within 30 days of Visit 1.
• Subjects with known hypersensitivity to study medications, or to any diagnostic agents to be used in the study.
• 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.
• Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol.

Where it is running

• Clinical Investigative Site — Pheonix, Arizona, United States
• Clinical Investigator Site — Garden Grove, California, United States
• Clinical Investigator Site — Glendale, California, United States
• Clinical Investigator Site — Inglewood, California, United States
• Clinical Investigator Site — Newport Beach, California, United States
• Clinical Investigator Site — Petaluma, California, United States
• Clinical Investigator Site — Rancho Cordova, California, United States
• Clinical Investigator Site — Aurora, Colorado, United States
• Clinical Investigator Site — Crystal River, Florida, United States
• Clinical Investigator Site — Largo, Florida, United States
• Clinical Investigator Site — Tampa, Florida, United States
• Clinical Investigator Site — Atlanta, Georgia, United States
• Clinical Investigator Site — Morrow, Georgia, United States
• Clinical Investigator Site — Pittsburg, Kansas, United States
• Clinical Investigator Site — Louisville, Kentucky, United States
• Clinical Investigator Site — Havre de Grace, Maryland, United States
• Clinical Investigator Site — Medina, Minnesota, United States
• Clinical Investigator Site — Kansas City, Missouri, United States
• Investigative Site — St Louis, Missouri, United States
• Clinical Investigator Site — Washington, Missouri, United States
• Clinical Investigator Site — Garner, North Carolina, United States
• Clinical Investigator Site — Cincinnati, Ohio, United States
• Clinical Investigator Site — Cranberry Township, Pennsylvania, United States
• Clinical Investigator Site — Smyrna, Tennessee, United States
• Clinical Investigator Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.