CompletedPhase 2

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

United States500 participantsStarted 2012-05

Plain-language 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.

Who can participate

Age range1 Year

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sustained Clinical Cure

Timeframe: Day 18

Trial details

NCT IDNCT01532336

SponsorNovaBay Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-05

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