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

A Randomized, Double-Masked, Vehicle-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment (MR-139), in Subjects With Blepharitis

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

Study Overview

• Status: Terminated
• Conditions: Blepharitis
• Intervention / Treatment: Drug: Pimecrolimus 0.3% Ophthalmic Ointment; Drug: Placebo Ophthalmic Ointment

Detailed Description

The study is designed to evaluate Pimecrolimus 0.3% Ophthalmic Ointment in subjects with blepharitis to complete resolution (score = 0 on grading scale of 0-4) for eyelid debris after BID use at Week 6 in the Study Eye.

• Study Type: Interventional
• Enrollment (Actual): 477
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Pheonix, Arizona, United States, 85032
      • Clinical Investigative Site
  • California
    • Garden Grove, California, United States, 92843
      • Clinical Investigator Site
    • Glendale, California, United States, 91204
      • Clinical Investigator Site
    • Inglewood, California, United States, 90301
      • Clinical Investigator Site
    • Newport Beach, California, United States, 92663
      • Clinical Investigator Site
    • Petaluma, California, United States, 94954
      • Clinical Investigator Site
    • Rancho Cordova, California, United States, 95670
      • Clinical Investigator Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Clinical Investigator Site
  • Florida
    • Crystal River, Florida, United States, 34429
      • Clinical Investigator Site
    • Largo, Florida, United States, 33773
      • Clinical Investigator Site
    • Tampa, Florida, United States, 33603
      • Clinical Investigator Site
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • Clinical Investigator Site
    • Morrow, Georgia, United States, 30260
      • Clinical Investigator Site
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Clinical Investigator Site
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Clinical Investigator Site
  • Maryland
    • Havre de Grace, Maryland, United States, 21078
      • Clinical Investigator Site
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Clinical Investigator Site
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Clinical Investigator Site
    • St Louis, Missouri, United States, 63131
      • Investigative Site
    • Washington, Missouri, United States, 63090
      • Clinical Investigator Site
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • Clinical Investigator Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Clinical Investigator Site
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Clinical Investigator Site
  • Tennessee
    • Smyrna, Tennessee, United States, 37167
      • Clinical Investigator Site
  • Texas
    • Austin, Texas, United States, 78731
      • Clinical Investigator Site
    • Lakeway, Texas, United States, 78738
      • Clinical Investigator Site
    • San Antonio, Texas, United States, 78229
      • Clinical Investigator Site
  • Utah
    • Clinton, Utah, United States, 84015
      • Clinical Investigator Site
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Clinical Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pimecrolimus 0.3% Ophthalmic Ointment; Study Drug	Drug: Pimecrolimus 0.3% Ophthalmic Ointment; Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
Placebo Comparator: Placebo Ophthalmic Ointment; Placebo	Drug: Placebo Ophthalmic Ointment; Placebo will be applied twice a day to both eyelid margins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Discomfort Score	Proportion with at least 50% reduction from baseline in ODS at Week 6. Ocular discomfort is assessed by visual analog scale on a scale from 0-100 where 0 indicates no discomfort and 100 indicates maximum. A higher score indicates a worse outcome.	6 weeks
Collarettes	Proportion of complete resolution for collarettes (score =0 on grading scale 0-4) at Week 6. A higher score indicates a worse outcome.	6 weeks
Eyelid Redness	Proportion of complete resolution (score =0 on grading scale 0-4) for eyelid redness (erythema) at Week 6. A higher score indicates a worse outcome.	6 weeks
Ocular Discomfort Score	The mean change from baseline in ODS at Week 6. Ocular discomfort is assessed by visual analog scale on a scale from 0-100 where 0 indicates no discomfort and 100 indicates maximum. A higher score indicates a worse outcome.	6 weeks
Blepharitis Symptom Measurement	Proportion of complete resolution (score =0 on grading scale of 0-3) for the Eye Irritation Symptom on the BLISS at Week 6. A higher score indicates a worse outcome.	6 weeks
Eyelid Meibum Character	Proportion of complete resolution (score = 0 on grading scale 0-24 for upper lid; 0-15 for lower lid) for eyelid meibum character at Week 6. A higher score indicates a worse outcome.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyelid Swelling	Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid swelling. A higher score indicates a worse outcome.	6 weeks
Eyelid Redness	Complete resolution (score =0 on grading scale 0-4) and change from baseline for eyelid redness. A higher score indicates a worse outcome.	6 weeks
Eyelid Redness	Complete resolution (score =0 on grading scale 0-4) and change from baseline for eyelid redness. A higher score indicates a worse outcome.	12 weeks
Eyelid Meibomian Gland Plugging	Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid meibomian gland plugging. A higher score indicates a worse outcome.	12 weeks
Eyelid Meibum Character	Complete resolution and change from baseline for eyelid meibum character	12 weeks
Eyelid Swelling	Completion resolution (score =0 on grading scale 0-4) and change from baseline for eyelid swelling. A higher score indicates a worse outcome.	12 weeks

Collaborators and Investigators

• Sponsor: Famy Life Sciences, a Viatris Company
• Investigators: Study Director: Marian Macsai, MD, Viatris Eye Care Division

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Actual): September 9, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Dermatologic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Calcineurin Inhibitors; pimecrolimus
• Other Study ID Numbers: PCLS-OMZ-3001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No