Pimecrolimus Ointment for Blepharitis

Not currently recruiting at 30 trial locations

Overseen By Marian Macsai, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Famy Life Sciences, a Viatris Company

Disqualifiers: COVID, Herpetic keratitis, Neurotrophic keratitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ointment called Pimecrolimus to determine its effectiveness in treating blepharitis, an eye condition causing inflammation and discomfort on the eyelids. Researchers aim to assess both the efficacy and safety of this ointment. Participants will receive either the Pimecrolimus ointment or a placebo (a non-active treatment) for comparison. Individuals who have previously experienced blepharitis, especially those for whom lid hygiene has been ineffective, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

The protocol does not specify if you need to stop your current medications. However, you cannot have received other treatments for blepharitis within 30 days of the first visit.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have received other treatments for blepharitis within 30 days of the first visit.

Is there any evidence suggesting that Pimecrolimus 0.3% Ophthalmic Ointment is likely to be safe for humans?

Research has shown that Pimecrolimus ointment is safe for conditions like atopic dermatitis, a type of skin inflammation. In past studies, most people found Pimecrolimus well-tolerated. Common side effects, if they occur, are usually mild, such as slight burning or irritation at the application site.

Clinical tests provide some evidence for using Pimecrolimus 0.3% ointment to treat blepharitis (inflammation of the eyelids). So far, data does not indicate any major safety concerns. As a Phase 3 trial, this study follows earlier safety checks, suggesting Pimecrolimus is expected to be reasonably safe. This trial will offer more detailed information about its safety for blepharitis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for blepharitis?

Most treatments for blepharitis focus on managing symptoms with antibiotics and steroids, but pimecrolimus ointment offers a new approach by targeting the immune response. Pimecrolimus is a topical calcineurin inhibitor, which means it specifically reduces inflammation without the potential side effects of steroids. Researchers are excited because this could mean a safer, more effective option for controlling blepharitis symptoms. Additionally, the ointment form is easy to apply directly to the eyelids, providing localized treatment where it's needed most.

What evidence suggests that Pimecrolimus might be an effective treatment for blepharitis?

Research has shown that pimecrolimus ointment can help treat blepharitis, an inflammation of the eyelids. One study found that about 79% of patients with blepharitis improved with pimecrolimus. This trial will compare the effectiveness of Pimecrolimus 0.3% Ophthalmic Ointment, which participants may receive, with a placebo ointment. Although pimecrolimus is mainly used for skin problems, its use as an eye ointment appears promising for blepharitis. This treatment targets inflammation, a main cause of blepharitis. ^{1 2 6 7 8}

Who Is on the Research Team?

Marian Macsai, MD

Principal Investigator

Viatris Eye Care Division

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Be literate and able to complete questionnaires independently, or comprehend the questionnaires with the help of a parent/guardian or interviewer in the case of pediatric patients

I have given my consent verbally and in writing to participate.

Have a Corrected Distance Visual Acuity (CDVA) ≥ 0.7 logMar in each eye, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria

I haven't had treatments for blepharitis in the last 30 days.

Subjects unable to adhere to the study protocol

I got a COVID vaccine or recovered from COVID less than a week ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pimecrolimus 0.3% Ophthalmic Ointment or placebo for 6 weeks to evaluate efficacy and safety

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pimecrolimus

Trial Overview 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).

How Is the Trial Designed?

Group I: Pimecrolimus 0.3% Ophthalmic Ointment Active Control 1 Intervention

Study Drug

Group II: Placebo Ophthalmic Ointment Placebo Group 1 Intervention

Placebo

Pimecrolimus is already approved in United States, European Union for the following indications:

Approved in United States as Elidel for:

• Mild to moderate atopic dermatitis (eczema) in non-immunocompromised adults and children 2 years of age and older

Approved in European Union as Elidel for:

• Mild to moderate atopic dermatitis (eczema) in non-immunocompromised adults and children 2 years of age and older

Who Is Running the Clinical Trial?

Famy Life Sciences, a Viatris Company

Lead Sponsor

Trials

1

Recruited

480+

Published Research Related to This Trial

In a large study of 5,665 patients with atopic dermatitis, pimecrolimus ointment was found to be effective, with 79.3% of physicians and 76.5% of patients rating its efficacy as 'good'.

The treatment was well-tolerated, with 87.2% of physicians and 83.1% of patients reporting good tolerability, and it significantly improved quality of life for both children and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Post-marketing surveillance on treatment of 5,665 patients with atopic dermatitis using the calcineurin inhibitor pimecrolimus: positive effects on major symptoms of atopic dermatitis and on quality of life]. Sunderkötter, C., Weiss, JM., Bextermöller, R., et al.[2014]

Pimecrolimus cream 1% is effective in treating atopic eczema, providing rapid relief from itching and reducing redness and swelling in up to 70% of patients within the first three weeks of treatment.

It is well tolerated, even on sensitive skin areas like the face and neck, with low blood concentrations and no significant systemic side effects observed in both short- and long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus: a review of pre-clinical and clinical data. Graham-Brown, RA., Grassberger, M.[2014]

In two 26-week clinical trials involving 403 children aged 2 to 17 with mild to moderate atopic dermatitis, pimecrolimus cream significantly improved parents' quality of life compared to a vehicle treatment, particularly noted at the 6-week mark.

While both groups showed improvements in quality of life over time, pimecrolimus demonstrated statistically significant superiority over the vehicle during the initial treatment phase, indicating its efficacy in managing pediatric atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefit of pimecrolimus (Elidel, SDZ ASM 981) on parents' quality of life in the treatment of pediatric atopic dermatitis. Whalley, D., Huels, J., McKenna, SP., et al.[2019]

In a study of 192 adults with moderate to severe atopic dermatitis, pimecrolimus cream 1% significantly reduced the need for topical corticosteroids, with only 14.2% of treatment days requiring corticosteroids compared to 37.2% in the control group.

Pimecrolimus treatment led to a longer median time to first flare (144 days) and a higher percentage of patients (44.8%) remaining flare-free compared to the control group (18.8%), indicating its efficacy in managing atopic dermatitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Meurer, M., Fölster-Holst, R., Wozel, G., et al.[2017]

In a study involving 12 patients with chronic hand dermatitis, pimecrolimus cream 1% was applied twice daily and resulted in low blood concentrations of the drug, indicating minimal systemic absorption and a favorable safety profile.

The treatment was well tolerated with no serious adverse events, and 85% of subjects showed significant improvement in their condition by day 22, demonstrating its efficacy in managing chronic hand dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occlusive treatment of chronic hand dermatitis with pimecrolimus cream 1% results in low systemic exposure, is well tolerated, safe, and effective. An open study. Thaçi, D., Steinmeyer, K., Ebelin, ME., et al.[2017]

Pimecrolimus cream 1% is minimally absorbed through the skin and has a favorable safety profile, with the most common side effects being transient local reactions like skin burning.

While there is an increased risk of herpes simplex virus infections in children using pimecrolimus compared to a placebo, it does not increase the risk of skin infections compared to topical corticosteroids and does not cause corticosteroid-related side effects like skin atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance. Langley, RG., Luger, TA., Cork, MJ., et al.[2014]

Pimecrolimus cream is a new topical immunosuppressant approved for treating mild to moderate atopic dermatitis in patients aged 2 years and older, and it is the first in its class to be recommended for first-line use.

It can be used for both short-term treatment of inflamed skin and as a long-term preventive measure against flare-ups, with claims that it can reduce or eliminate the need for steroid treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream for atopic dermatitis. [2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9436712/

The Efficacy and Safety of Pimecrolimus in Patients With ... Topical CNI showed good and beneficial outcomes when treating inflammatory skin disorders. Of those, topical immunomodulatory agents ...

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/1819582

Long-term Safety of Topical Pimecrolimus and ... Treatment response rates for blepharitis were 78.8% with pimecrolimus and 89.9% with tacrolimus (P = .06). In multivariable logistic regression ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00124709

Safety and Efficacy of Pimecrolimus Cream 1% in Atopic ... This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7063702/

Topical immunosuppressants for blepharitis in adults - PMC DES as a sequela of chronic blepharitis has been associated with significant adverse impact on quality of life and psychiatric morbidities ( ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-3-to-evaluate-efficacy-safety-pimecrolimus-0-ophthalmic-ointment-trial-nct06400511

A Phase 3 study of Pimecrolimus Ophthalmic Ointment ... If the medication is effective, participants may experience improvement or resolution of their blepharitis symptoms.

6. empr.com empr.com/news/no-significant-benefit-seen-with-pimecrolimus-eye-ointment-in-blepharitis-trial/

No Significant Benefit Seen With Pimecrolimus Eye ... Treatment with pimecrolimus 0.3% ophthalmic ointment did not significantly improve blepharitis compared with placebo. Topline data were ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4657476/

Pimecrolimus in atopic dermatitis: Consensus on safety ... A long-term study of safety and allergic comorbidity development in a randomized trial of pimecrolimus cream in infants with atopic dermatitis. J Invest ...

8. clinicaltrialsarena.com clinicaltrialsarena.com/news/viatris-blepharitis-ointment-fails-phase-iii-trial/

Viatris' blepharitis ointment fails Phase III trial Viatris' investigational blepharitis ointment failed to achieve the primary endpoint in its Phase III trial, prompting the company to reconsider the drug's ...