Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis (BACTOvation™)

May 26, 2015 updated by: NovaBay Pharmaceuticals, Inc.

A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis

The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").

Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:

  • Visit 1: Screening, Day 1
  • Visit 2: Day 3 (±1)
  • Visit 3: Day 5 (+1) Test of Cure/Exit

IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.

Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
    • Arizona
      • Phoenix, Arizona, United States, 85032
    • California
      • Anaheim, California, United States, 92804
      • Bellflower, California, United States, 90706
      • Glendale, California, United States, 91204
      • Huntington Beach, California, United States, 92647
    • Florida
      • Clearwater, Florida, United States, 33761
    • Georgia
      • Woodstock, Georgia, United States, 30189
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kansas
      • Newton, Kansas, United States, 67114
    • New Jersey
      • Whitehouse Station, New Jersey, United States, 08889
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
      • Winston Salem, North Carolina, United States, 27101
    • Ohio
      • Cincinnati, Ohio, United States, 45246
      • Dayton, Ohio, United States, 45432
    • Texas
      • Corsicana, Texas, United States, 75110
      • San Antonio, Texas, United States, 78215
    • Utah
      • Clinton, Utah, United States, 84015
    • Virginia
      • Charlottesville, Virginia, United States, 22902
      • Midlothian, Virginia, United States, 23113
    • Washington
      • Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1 year of age and older
  • Bulbar conjunctival injection
  • Conjunctival discharge/exudate
  • Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
  • Other inclusion criteria per protocol

Exclusion Criteria:

  • Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis
  • Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment
  • Other exclusion criteria per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auriclosene Solution 0.3%
Dosed QID for 4 Days
Drug: Auriclosene Solution 0.3%
Ophthalmic solution dispensed as drops onto the eye
Other Names:
  • NVC-422
Placebo Comparator: Auriclosene Vehicle
Dosed QID for 4 days
Drug: Auriclosene Vehicle
Ophthalmic Vehicle solution dispensed as drops onto the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological Success
Time Frame: 5 days
Eradication of all pre-therapy isolates
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure
Time Frame: 5 days
Resolution of all signs and symptoms
5 days

Other Outcome Measures

Outcome Measure
Time Frame
Resolution of individual ocular signs and symptoms
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovaBay Pharmaceuticals, Inc.

Investigators

  • Study Director: David W. Stroman, Ph.D., NovaBay Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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