Conjunctivitis: A Phase 3, multi-center, randomized, double-masked study to evaluate the clinical efficacy and safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension compared to PVP-Iodine and Placebo in the treatment of adenoviral and bacterial Conjunctivitis

The clinical presentation of conjunctivitis is often nonspecific and differential diagnosis of different types of conjunctivitis can be challenging. Diagnostic testing to differentiate the underlying cause of infection is rarely performed in a clinical setting; misdiagnosis can occur in up to 50% of cases, which often results in improper antibiotic treatment. Currently there is no approved medication for the treatment of adenoviral conjunctivitis. An unmet need therefore exists for a safe and efficacious treatment that addresses infectious conjunctivitis (adenoviral and bacterial). By combining PVP-I, a potent topical antiseptic with proven antiviral and antibacterial activity, with dexamethasone, a topical steroid, SHP640 should enable the treatment of both the infectious and inflammatory components of adenoviral and bacterial conjunctivitis even when the cause of infection is unclear. The primary objective of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and watery conjunctival discharge) compared with placebo in the treatment of subjects with adenoviral and bacterial conjunctivitis in the study eye at Visit 3 (Day 6).