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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by NovaBay Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01877694
First received: June 7, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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. Three visits will be required for this study.


Condition Intervention Phase
Bacterial Conjunctivitis
Drug: Auriclosene Ophthalmic Solution
Drug: Vehicle Ophthalmic Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis

Resource links provided by NLM:


Further study details as provided by NovaBay Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Microbiological Success [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Eradication of all pre-therapy isolates


Secondary Outcome Measures:
  • Clinical Cure [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Resolution of all signs and symptoms


Other Outcome Measures:
  • Resolution of individual ocular signs and symptoms [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auriclosene Ophthalmic Solution
Dosed for 4 days
Drug: Auriclosene Ophthalmic Solution
Placebo Comparator: Vehicle Ophthalmic Solution
Dosed for 4 days
Drug: Vehicle Ophthalmic Solution

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877694

Contacts
Contact: David Stroman dstroman@novabay.com

Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35244
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85032
United States, California
Recruiting
Anaheim, California, United States, 92804
Recruiting
Bellflower, California, United States, 90706
Recruiting
Glendale, California, United States, 91204
Recruiting
Huntington Beach, California, United States, 92647
United States, Florida
Recruiting
Clearwater, Florida, United States, 33761
United States, Georgia
Recruiting
Woodstock, Georgia, United States, 30189
United States, Indiana
Recruiting
Evansville, Indiana, United States, 47714
United States, Kansas
Recruiting
Newton, Kansas, United States, 67114
United States, New Jersey
Recruiting
Whitehouse Station, New Jersey, United States, 08889
United States, North Carolina
Recruiting
Huntersville, North Carolina, United States, 28078
Recruiting
Winston Salem, North Carolina, United States, 27101
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45246
Recruiting
Dayton, Ohio, United States, 45432
United States, Texas
Recruiting
Corsicana, Texas, United States, 75110
Recruiting
San Antonio, Texas, United States, 78215
United States, Utah
Recruiting
Clinton, Utah, United States, 84015
United States, Virginia
Recruiting
Charlottesville, Virginia, United States, 22902
Recruiting
Midlothian, Virginia, United States, 23113
United States, Washington
Not yet recruiting
Spokane, Washington, United States, 99202
Sponsors and Collaborators
NovaBay Pharmaceuticals, Inc.
Investigators
Study Director: David W. Stroman, Ph.D. NovaBay Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01877694     History of Changes
Other Study ID Numbers: CL1301
Study First Received: June 7, 2013
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NovaBay Pharmaceuticals, Inc.:
pink eye

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014