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

Inclusion Criteria:

1. Male or female subjects aged ≥ 2 years of age or older at Visit 1, with a diagnosisof blepharitis confirmed by the investigator.

2. Subjects under 18 must able to be examined at the slit lamp (handheld) withoutsystemic 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 writteninformed consent and sign the HIPAA form (or equivalent, if applicable), approved bythe appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Wheneverpractical and appropriate per local requirements, a child's assent should also besought 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 logMarin 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 theability to self-administer or receive topical treatment twice a day to their eyelidmargins.

8. Be literate and able to complete questionnaires independently, or in the case ofpediatric patients, can comprehend the questionnaires with the help of aparent/guardian or interviewer.

9. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test atVisit 1 and must be willing to use an adequate method of contraception throughoutthe 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 symptomsless 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 andsymptoms, including but not limited to lagophthalmos, malposition of the eyelid ortumor(s) of the eyelid or eyelid margin.

4. Subjects who have received other treatments for blepharitis within 30 days of Visit

6. Subjects with known hypersensitivity to study medications, or to any diagnosticagents to be used in the study.

7. Subjects who are currently enrolled in an investigational drug or device study orhave used an investigational drug or device within the 30 days prior to the baselinevisit and during the treatment period.

8. Subjects who, in the opinion of the investigator, would be unable to adhere to thestudy protocol.