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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaBay Pharmaceuticals, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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