BlepharitisPhase 3NCT06400511
A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment
A Phase 3 study testing Pimecrolimus 0.3% Ophthalmic Ointment in people with Blepharitis, run by Famy Life Sciences, a Viatris Company at 29 sites in United States.
Trial summary
The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- Pimecrolimus 0.3% Ophthalmic Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 477 participants
- Where
- 29 sitesUnited States
- Study dates
- 22 Apr 2024to 15 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Clinical Investigator Site
Atlanta, Georgia, 30339
Clinical Investigator Site
Aurora, Colorado, 80045
Clinical Investigator Site
Austin, Texas, 78731
Clinical Investigator Site
Cincinnati, Ohio, 45242
Clinical Investigator Site
Clinton, Utah, 84015
Clinical Investigator Site
Cranberry Township, Pennsylvania, 16066
Clinical Investigator Site
Crystal River, Florida, 34429
Clinical Investigator Site
Garden Grove, California, 92843
Clinical Investigator Site
Garner, North Carolina, 27529
Clinical Investigator Site
Glendale, California, 91204
Clinical Investigator Site
Havre de Grace, Maryland, 21078
Clinical Investigator Site
Inglewood, California, 90301
Clinical Investigator Site
Kansas City, Missouri, 64154
Clinical Investigator Site
Lakeway, Texas, 78738
Clinical Investigator Site
Largo, Florida, 33773
Clinical Investigator Site
Louisville, Kentucky, 40206
Clinical Investigator Site
Lynchburg, Virginia, 24502
Clinical Investigator Site
Medina, Minnesota, 55340
Clinical Investigator Site
Morrow, Georgia, 30260
Clinical Investigator Site
Newport Beach, California, 92663
Clinical Investigator Site
Petaluma, California, 94954
Clinical Investigative Site
Pheonix, Arizona, 85032
Clinical Investigator Site
Pittsburg, Kansas, 66762
Clinical Investigator Site
Rancho Cordova, California, 95670
Clinical Investigator Site
San Antonio, Texas, 78229
Clinical Investigator Site
Smyrna, Tennessee, 37167
Investigative Site
St Louis, Missouri, 63131
Clinical Investigator Site
Tampa, Florida, 33603
Clinical Investigator Site
Washington, Missouri, 63090
About this study
Official title: 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.
Read the 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.
- Conditions
- Blepharitis
- Being tested
- Pimecrolimus 0.3% Ophthalmic Ointment, Placebo Ophthalmic Ointment
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimecrolimus 0.3% Ophthalmic OintmentDrug
Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
Placebo Ophthalmic OintmentDrug
Placebo will be applied twice a day to both eyelid margins.
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus 0.3% Ophthalmic Ointment | Active comparator | Study Drug Receives: Drug: Pimecrolimus 0.3% Ophthalmic Ointment |
| Placebo Ophthalmic Ointment | Placebo comparator | Placebo Receives: Drug: Placebo Ophthalmic Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Study Drug
Complete Resolution (score =0 on grading scale 0-4) of eyelid debris. A higher score indicates a worse outcome.
Measured: 6 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start22 Apr 2024
- Primary completion9 Sep 2025
- Study completion15 Oct 2025
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Famy Life Sciences, a Viatris Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marian Macsai, MD, Study director, Viatris Eye Care Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400511
- Sponsor's protocol ID
- PCLS-OMZ-3001
- Status last verified
- Jan 2026
- First submitted
- 1 May 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06400511
- Acronym / sponsor ID
- PCLS-OMZ-3001
- Conditions
- Blepharitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Famy Life Sciences, a Viatris CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus 0.3% Ophthalmic Ointment | Active comparator | Drug: Pimecrolimus 0.3% Ophthalmic OintmentStudy Drug |
| Placebo Ophthalmic Ointment | Placebo comparator | Drug: Placebo Ophthalmic OintmentPlacebo |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
- Subjects who have not responded adequately to lid hygiene in the past (self-reported).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimecrolimus 0.3% Ophthalmic OintmentPimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins. | Drug | Pimecrolimus 0.3% Ophthalmic Ointment |
| Placebo Ophthalmic OintmentPlacebo will be applied twice a day to both eyelid margins. | Drug | Placebo Ophthalmic Ointment |
Primary outcome
Efficacy of Study Drug
Time frame: 6 weeks
Complete Resolution (score =0 on grading scale 0-4) of eyelid debris. A higher score indicates a worse outcome.
6 secondary outcomes
Ocular Discomfort Score
Time frame: 6 weeks
Collarettes
Time frame: 6 weeks
Eyelid Redness
Time frame: 6 weeks
Ocular Discomfort Score
Time frame: 6 weeks
Blepharitis Symptom Measurement
Time frame: 6 weeks
Eyelid Meibum Character
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marian Macsai, MD study director
Viatris Eye Care Division
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimecrolimus 0.3% Ophthalmic Ointment in people with Blepharitis, run by Famy Life Sciences, a Viatris Company at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Study Drug (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.