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

Completed · Phase 2

Conditions studied: Adenoviral Conjunctivitis

In brief

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.

Key facts

Study ID

NCT01532336

Run by

NovaBay Pharmaceuticals, Inc.

People needed

500

Starts

2012-05-01

Expected to finish

2014-08-01

Last updated by the study team

2015-05-28

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
• Bulbar conjunctival injection
• Other inclusion criteria per protocol

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Petaluma, California, United States
• Study site — San Diego, California, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville Beach, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Albany, Georgia, United States
• Study site — Kailua, Hawaii, United States
• Study site — Glenview, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Shawnee Mission, Kansas, United States
• Study site — Hazard, Kentucky, United States
• Study site — Winchester, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Hicksville, New York, United States
• Study site — Rockville Centre, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — High Point, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Recife, Pernambuco, Brazil
• Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

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