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

Inclusion Criteria:

1. Age 1 and older

2. Clinical diagnosis of acute bacterial conjunctivitis with at least one eyeexhibiting conjunctival discharge graded ≥ 2 as well as palpebral conjunctivalinjection graded ≥ 2 AND bulbar conjunctival injection graded ≥ 2 with onset ≤ 4days as reported by the subject.

3. Negative test result on AdenoPlus® adenovirus test.

4. Snellen visual acuity (VA) equal to or better than 20/200 in each eye using currentcorrective lenses, if required (or if worn) and/or using pinhole if subject'scorrective lenses are not available at the time of exam. Every attempt should bemade to obtain a VA measurement in children and, if it is unobtainable, the decisionas to whether the criterion is met will be at the investigator's discretion.

5. Female subjects must be 1-year postmenopausal, surgically sterilized, or women ofchildbearing potential with a negative urine pregnancy test at Visit 1. Women ofchildbearing potential must use an acceptable form of contraception throughout thestudy. Acceptable methods include the use of at least one of the following:intrauterine (intrauterine device), hormonal (oral, injection, patch, implant,ring), barrier with spermicide (condom, diaphragm), or abstinence.

6. Able to self-administer study medication or to have the study medicationadministered by a caregiver throughout the study period.

7. Must have signed written consent from the subject prior to participation in anystudy-related procedures if the subject is 18 years of age or older, or from thelegally authorized representative/guardian if the subject is under 18 years of age.

8. Must have the signature of the subject on the assent form, as required byInstitutional Review Board (IRB) guidelines, if the subject is under 18 years ofage.

Exclusion Criteria:

1. Suspected viral or allergic conjunctivitis or suspected fungal or acanthamoebainfections at Screening in either eye.

2. Suspected iritis/uveitis or episcleritis/scleritis at Screening in either eye orhistory of either condition.

3. Active ulcerative keratitis, specifically any epithelial loss greater than punctatekeratitis (eg, confluent epithelial loss or any subepithelial infiltration) ineither eye.

4. History of recurrent corneal erosion syndrome, either idiopathic or secondary toprevious 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 immunosuppressivetherapy (including chemotherapy).

7. Any use of topical ophthalmic medications, including tear substitutes, within 2hours 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 isprohibited throughout the study period in either eye.

9. Use of topical ophthalmic anti-inflammatory agents (eg, nonsteroidalanti-inflammatory drugs [NSAIDs] or steroids, including steroid-antibioticcombinations) 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 andthroughout the study period. Use of a topical dermatologic antibiotic is permitted.

11. Use of systemic steroids within 14 days of screening and throughout the studyperiod. Inhaled, intranasal, and topical dermatological steroids are permitted.

12. Contact lens wear during the study period in study eye. (contact lens wear in anuntreated 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 toScreening in either eye.

16. Known hypersensitivity to vancomycin, petrolatum, or mineral oil