A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment
NCT ID: NCT06400511
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
477 participants
INTERVENTIONAL
2024-04-22
2025-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pimecrolimus 0.3% Ophthalmic Ointment
Study Drug
Pimecrolimus 0.3% Ophthalmic Ointment
Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
Placebo Ophthalmic Ointment
Placebo
Placebo Ophthalmic Ointment
Placebo will be applied twice a day to both eyelid margins.
Interventions
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Pimecrolimus 0.3% Ophthalmic Ointment
Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
Placebo Ophthalmic Ointment
Placebo will be applied twice a day to both eyelid margins.
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
ALL
No
Sponsors
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Famy Life Sciences, a Viatris Company
INDUSTRY
Responsible Party
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Principal Investigators
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Marian Macsai, MD
Role: STUDY_DIRECTOR
Viatris Eye Care Division
Locations
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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
Clinical Investigator Site
Lakeway, Texas, United States
Clinical Investigator Site
San Antonio, Texas, United States
Clinical Investigator Site
Clinton, Utah, United States
Clinical Investigator Site
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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PCLS-OMZ-3001
Identifier Type: -
Identifier Source: org_study_id
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