Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis (BAYnovation™)

A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

The purpose of this study is to evaluate the clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc). Subjects will be randomly assigned to receive either NVC-422 or Vehicle.

This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle"). Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits: Visit 1: Screening, Day 1 Visit 2: Day 3 Visit 3: Day 6 Visit 4: Day 11 End of Treatment (EOT) Visit 5: Day 18 Test-of-Cure (TOC) Visit 6: Day 42 Follow-up Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.

Inclusion Criteria: Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less Bulbar conjunctival injection Other inclusion criteria per protocol Exclusion Criteria: Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation Other exclusion criteria per protocol