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

NCT01532336 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2015-05-28

No results posted yet for this study

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.

Conditions

  • Adenoviral Conjunctivitis

Interventions

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

Sponsors & Collaborators

  • NovaBay Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Stroman, Ph.D. · NovaBay Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • United States
  • Brazil
  • India
  • Sri Lanka

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01532336 on ClinicalTrials.gov