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

Adenoviral Conjunctivitis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoviral Conjunctivitis
• Conjunctivitis

• NCT number: NCT01532336
• Study type: Interventional
• Source: NovaBay Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: May 2012
• Completion date: August 2014