Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis

Overview

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.

Conditions

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Eligibility

Locations (58)

Outcomes