Clinical trial NCT06400511: A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Blepharitis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 477
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Study Drug
timeFrame: 6 weeks
Secondary outcomes:
measure: Ocular Discomfort Score
timeFrame: 6 weeks
measure: Collarettes
timeFrame: 6 weeks
measure: Eyelid Redness
timeFrame: 6 weeks
measure: Ocular Discomfort Score
timeFrame: 6 weeks
measure: Blepharitis Symptom Measurement
timeFrame: 6 weeks
measure: Eyelid Meibum Character
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Investigative Site
state: Arizona
city: Garden Grove
country: United States
facility: Clinical Investigator Site
state: California
city: Glendale
country: United States
facility: Clinical Investigator Site
state: California
city: Inglewood
country: United States
facility: Clinical Investigator Site
state: California
city: Newport Beach
country: United States
facility: Clinical Investigator Site
state: California
city: Petaluma
country: United States
facility: Clinical Investigator Site
state: California
city: Rancho Cordova
country: United States
facility: Clinical Investigator Site
state: California
city: Aurora
country: United States
facility: Clinical Investigator Site
state: Colorado
city: Crystal River
country: United States
facility: Clinical Investigator Site
state: Florida
city: Largo
country: United States
facility: Clinical Investigator Site
state: Florida
city: Tampa
country: United States
facility: Clinical Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Investigator Site
state: Georgia
city: Morrow
country: United States
facility: Clinical Investigator Site
state: Georgia
city: Pittsburg
country: United States
facility: Clinical Investigator Site
state: Kansas
city: Louisville
country: United States
facility: Clinical Investigator Site
state: Kentucky
city: Havre De Grace
country: United States
facility: Clinical Investigator Site
state: Maryland
city: Medina
country: United States
facility: Clinical Investigator Site
state: Minnesota
city: Kansas City
country: United States
facility: Clinical Investigator Site
state: Missouri
city: Saint Louis
country: United States
facility: Investigative Site
state: Missouri
city: Washington
country: United States
facility: Clinical Investigator Site
state: Missouri
city: Garner
country: United States
facility: Clinical Investigator Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Investigator Site
state: Ohio
city: Cranberry Township
country: United States
facility: Clinical Investigator Site
state: Pennsylvania
city: Smyrna
country: United States
facility: Clinical Investigator Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Investigator Site
state: Texas
city: Lakeway
country: United States
facility: Clinical Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Investigator Site
state: Texas
city: Clinton
country: United States
facility: Clinical Investigator Site
state: Utah
city: Lynchburg
country: United States
facility: Clinical Investigator Site
state: Virginia
Study officials:
affiliation: Viatris Eye Care Division
name: Marian Macsai, MD
role: STUDY_DIRECTOR
References: