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

Bacterial conjunctivitis is common ocular disease caused by various types of bacteria
including methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant
Staphylococcus epidermidis (MRSE). External ocular infections such as those caused by MRSA or
MRSE frequently are not serious but in rare cases may be severe enough to threaten vision.
When ocular infections due to resistant organisms such as MRSA/MRSE do not respond to empiric
treatment with approved antibiotics, there are few treatment options. Vancomycin is one of
the few treatment options that has been shown to be effective against all clinical isolates
of MRSA/MRSE.

This study is a Phase 3 study to evaluate the safety and efficacy of a vancomycin
hydrochloride ophthalmic ointment in patients with moderate to severed Gram-positive
bacterial conjunctivitis including those with MRSA and MRSE. Subjects, who are adenovirus
negative, will be dosed with vancomycin hydrochloride ophthalmic ointment or placebo
(vehicle) 4 times daily for 7 days and evaluated for clinical and bacterial resolution of
their infection along with an assessment of the safety of the investigational product.

Inclusion Criteria:

1. Age 1 and older

2. Clinical diagnosis of acute bacterial conjunctivitis with at least one eye exhibiting
conjunctival discharge graded ≥ 2 as well as palpebral conjunctival injection graded ≥
2 AND bulbar conjunctival injection graded ≥ 2 with onset ≤ 4 days 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 current
corrective lenses, if required (or if worn) and/or using pinhole if subject's
corrective lenses are not available at the time of exam. Every attempt should be made
to obtain a VA measurement in children and, if it is unobtainable, the decision as 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 of
childbearing potential with a negative urine pregnancy test at Visit 1. Women of
childbearing potential must use an acceptable form of contraception throughout the
study. 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 medication administered
by a caregiver throughout the study period.

7. Must have signed written consent from the subject prior to participation in any
study-related procedures if the subject is 18 years of age or older, or from the
legally 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 by
Institutional Review Board (IRB) guidelines, if the subject is under 18 years of age.

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