NCT01532336

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: NovaBay Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Adenoviral Conjunctivitis

Interventions

Type	Name	Description
DRUG	NVC-422 Solution, 0.3%	NVC-422 Ophthalmic Solution dropped onto the eye
DRUG	NVC-422 Vehicle Solution	NVC-422 Vehicle Ophthalmic Solution dropped onto the eye

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2012-02-14
• Last updated: 2015-05-28

Locations

58 sites across 4 countries: United States, Brazil, India, Sri Lanka