Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis

Exclusion Criteria

• •1. Suspected viral or allergic conjunctivitis or suspected fungal or acanthamoeba infections at Screening in either eye.
• •2. Suspected iritis/uveitis or episcleritis/scleritis at Screening in either eye or history of either condition.
• •3. Active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis (eg, confluent epithelial loss or any subepithelial infiltration) in either eye.
• •4. History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome in study eye.
• •5. Uncontrolled systemic or debilitating disease (eg, cardiovascular disease, hypertension, diabetes, or cystic fibrosis) in the opinion of the Investigator.
• •6. Subjects who are immunocompromised (eg, HIV-positive); any use of immunosuppressive therapy (including chemotherapy).
• •7. Any use of topical ophthalmic medications, including tear substitutes, within 2 hours before Screening and throughout the study period in either eye.
• •8. Use of topical ophthalmic antimicrobial therapy within 48 hours prior to Screening. Use of topical ophthalmic antimicrobial therapy other than study medication is prohibited throughout the study period in either eye.
• •9. Use of topical ophthalmic anti-inflammatory agents (eg, nonsteroidal anti-inflammatory drugs \[NSAIDs\] or steroids, including steroid-antibiotic combinations) within 48 hours prior to Screening and throughout the study period.
• •10. Use of systemic antimicrobial therapy for active respiratory tract, urinary tract, skin/soft tissue, or otitis media infection within 72 hours prior to Screening and throughout the study period. Use of a topical dermatologic antibiotic is permitted.
• •11. Use of systemic steroids within 14 days of screening and throughout the study period. Inhaled, intranasal, and topical dermatological steroids are permitted.
• •12. Contact lens wear during the study period in study eye. (contact lens wear in an untreated fellow eye is allowed).
• •13. Ocular surgery (nonlaser or laser) within 6 weeks prior to Screening in study eye.
• •14. Pregnancy or lactation.
• •15. Participation in an ophthalmic drug or device research study within 30 days prior to Screening in either eye.
• •16. Known hypersensitivity to vancomycin, petrolatum, or mineral oil