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Calcineurin Inhibitor

Pimecrolimus Ointment for Blepharitis

Phase 3
Recruiting
Research Sponsored by Famy Life Sciences, a Viatris Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects under 18 must able to be examined at the slit lamp without systemic anesthesia
Male or female subjects aged ≥ 2 years with a diagnosis of blepharitis confirmed by the investigator
Must not have
Subjects who have received other treatments for blepharitis within 30 days of Visit 1
Subjects who have received a COVID vaccination or recovered from COVID-19 symptoms less than 1 week prior to baseline visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial aims to find out how well and how safe Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment works.

Who is the study for?
This trial is for people aged 2 years and older diagnosed with blepharitis, who haven't had success with lid hygiene. Participants need good vision, must be able to follow the study's rules including applying treatment twice daily, and women of childbearing age must test negative for pregnancy and use contraception. It excludes those recently treated for blepharitis or vaccinated/recovered from COVID-19 within a week before starting.
What is being tested?
The trial is testing Pimecrolimus 0.3% Ophthalmic Ointment against a placebo ointment to see if it's effective and safe in treating blepharitis. Participants will apply one of these treatments without knowing which one they're using (blind study).
What are the potential side effects?
Possible side effects may include irritation at the application site, allergic reactions if sensitive to ingredients, eye discomfort or redness. The exact side effects are being studied as part of this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 and can undergo an eye exam without needing anesthesia.
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I am 2 years or older and have been diagnosed with blepharitis.
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I have had an episode of eyelid inflammation before.
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I can follow the study rules, including applying a treatment to my eyelids twice daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had treatments for blepharitis in the last 30 days.
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I got a COVID vaccine or recovered from COVID less than a week ago.
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I have not participated in a drug or device study in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of Study Drug
Secondary study objectives
Eyelid Debris
Ocular Discomfort Score
Other study objectives
Eyelid Meibomian Gland Plugging
Eyelid Redness
Eyelid Swelling

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Pimecrolimus 0.3% Ophthalmic OintmentActive Control1 Intervention
Study Drug
Group II: Placebo Ophthalmic OintmentPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Famy Life Sciences, a Viatris CompanyLead Sponsor
Marian Macsai, MDStudy DirectorViatris Eye Care Division
1 Previous Clinical Trials
30 Total Patients Enrolled
~282 spots leftby Aug 2025
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