Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

Inclusion Criteria:

1. Subjects of any age at Visit 1.

2. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.

3. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye
(the same eye as the AdenoPlus positive eye) confirmed by the presence of the
following minimal clinical signs and symptoms in that same eye.

4. Be willing to discontinue contact lens wear for the duration of the study.

5. Have a Best Corrected Visual Acuity (BCVA) of 0.60 logarithm of the Minimum Angle of
Resolution (logMAR) or better in each eye as measured using an Early Treatment
Diabetic Retinopathy Study (ETDRS) chart.

6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

1. Have known or suspected intolerance or hypersensitivity to the investigational
product, closely related compounds, or any of the stated ingredients.

2. Prior enrollment in a FST100 or SHP640 clinical study.

3. Subjects who are employees, or immediate family members of employees (who are directly
related to study conduct), at the investigational site.

4. Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or
planned for the period of the study.

5. Have a preplanned overnight hospitalization during the period of the study.

6. Have active or history of ocular herpes.

7. Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more
consistent with the diagnosis of non-infectious conjunctivitis (except presumed
seasonal/perennial allergic conjunctivitis) or non-adenoviral ocular infection (eg,
bacterial, fungal, acanthamoebal, or other parasitic).

8. Other protocol defined exclusion criteria may apply