NCT06400511

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

29 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

May 1, 2024

Last Update Submit

January 6, 2026

Conditions

Blepharitis

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Study Drug

    Complete Resolution (score =0 on grading scale 0-4) of eyelid debris. A higher score indicates a worse outcome.

    6 weeks

Secondary Outcomes (6)

  • Ocular Discomfort Score

    6 weeks

  • Collarettes

    6 weeks

  • Eyelid Redness

    6 weeks

  • Ocular Discomfort Score

    6 weeks

  • Blepharitis Symptom Measurement

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Pimecrolimus 0.3% Ophthalmic Ointment

ACTIVE COMPARATOR

Study Drug

Drug: Pimecrolimus 0.3% Ophthalmic Ointment

Placebo Ophthalmic Ointment

PLACEBO COMPARATOR

Placebo

Drug: Placebo Ophthalmic Ointment

Interventions

Placebo Ophthalmic OintmentDRUG

Placebo will be applied twice a day to both eyelid margins.

Placebo Ophthalmic Ointment
Pimecrolimus 0.3% Ophthalmic OintmentDRUG

Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.

Pimecrolimus 0.3% Ophthalmic Ointment

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Clinical Investigative Site

Pheonix, Arizona, 85032, United States

Location

Clinical Investigator Site

Garden Grove, California, 92843, United States

Location

Clinical Investigator Site

Glendale, California, 91204, United States

Location

Clinical Investigator Site

Inglewood, California, 90301, United States

Location

Clinical Investigator Site

Newport Beach, California, 92663, United States

Location

Clinical Investigator Site

Petaluma, California, 94954, United States

Location

Clinical Investigator Site

Rancho Cordova, California, 95670, United States

Location

Clinical Investigator Site

Aurora, Colorado, 80045, United States

Location

Clinical Investigator Site

Crystal River, Florida, 34429, United States

Location

Clinical Investigator Site

Largo, Florida, 33773, United States

Location

Clinical Investigator Site

Tampa, Florida, 33603, United States

Location

Clinical Investigator Site

Atlanta, Georgia, 30339, United States

Location

Clinical Investigator Site

Morrow, Georgia, 30260, United States

Location

Clinical Investigator Site

Pittsburg, Kansas, 66762, United States

Location

Clinical Investigator Site

Louisville, Kentucky, 40206, United States

Location

Clinical Investigator Site

Havre de Grace, Maryland, 21078, United States

Location

Clinical Investigator Site

Medina, Minnesota, 55340, United States

Location

Clinical Investigator Site

Kansas City, Missouri, 64154, United States

Location

Investigative Site

St Louis, Missouri, 63131, United States

Location

Clinical Investigator Site

Washington, Missouri, 63090, United States

Location

Clinical Investigator Site

Garner, North Carolina, 27529, United States

Location

Clinical Investigator Site

Cincinnati, Ohio, 45242, United States

Location

Clinical Investigator Site

Cranberry Township, Pennsylvania, 16066, United States

Location

Clinical Investigator Site

Smyrna, Tennessee, 37167, United States

Location

Clinical Investigator Site

Austin, Texas, 78731, United States

Location

Clinical Investigator Site

Lakeway, Texas, 78738, United States

Location

Clinical Investigator Site

San Antonio, Texas, 78229, United States

Location

Clinical Investigator Site

Clinton, Utah, 84015, United States

Location

Clinical Investigator Site

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Blepharitis

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Marian Macsai, MD

    Viatris Eye Care Division

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 6, 2024

Study Start

April 22, 2024

Primary Completion

September 9, 2025

Study Completion

October 15, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

US(29)