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 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.