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Calcineurin Inhibitor

Pimecrolimus 0.3% Ophthalmic 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of Study Drug

Secondary outcome measures

Eyelid Debris

Ocular Discomfort Score

Other outcome measures

Eyelid Meibomian Gland Plugging

Eyelid Redness

Eyelid Swelling

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

0 / 4Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for this study?

"According to the details available on clinicaltrials.gov, this research is presently seeking eligible candidates. The trial's initial posting date was 22nd of April in 2024 and its most recent update occurred on May 1st, 2024."

Answered by AI

At how many distinct sites is this clinical trial being conducted?

"The current trial operates in 4 sites, situated in Newport Beach, Medina, and San Antonio alongside 2 additional locations. Choosing the nearest facility is crucial to reduce travel requirements for potential participants."

Answered by AI

Has the FDA provided approval for Pimecrolimus 0.3% Ophthalmic Ointment?

"Our assessment at Power rates the safety of Pimecrolimus 0.3% Ophthalmic Ointment as a level 3, based on its Phase 3 trial status which indicates existing efficacy data and substantial safety evidence from multiple assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06400511.

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