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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01877694
First received: June 7, 2013
Last updated: May 26, 2015
Last verified: May 2015
  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.


Condition Intervention Phase
Bacterial Conjunctivitis
Drug: Auriclosene Solution 0.3%
Drug: Auriclosene Vehicle
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 ]

Enrollment: 217
Study Start Date: June 2013
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auriclosene Solution 0.3%
Dosed QID for 4 Days
Drug: Auriclosene Solution 0.3%
Ophthalmic solution dispensed as drops onto the eye
Other Name: NVC-422
Placebo Comparator: Auriclosene Vehicle
Dosed QID for 4 days
Drug: Auriclosene Vehicle
Ophthalmic Vehicle solution dispensed as drops onto the eye

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.

  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

Locations
United States, Alabama
Birmingham, Alabama, United States, 35244
United States, Arizona
Phoenix, Arizona, United States, 85032
United States, California
Anaheim, California, United States, 92804
Bellflower, California, United States, 90706
Glendale, California, United States, 91204
Huntington Beach, California, United States, 92647
United States, Florida
Clearwater, Florida, United States, 33761
United States, Georgia
Woodstock, Georgia, United States, 30189
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Kansas
Newton, Kansas, United States, 67114
United States, New Jersey
Whitehouse Station, New Jersey, United States, 08889
United States, North Carolina
Huntersville, North Carolina, United States, 28078
Winston Salem, North Carolina, United States, 27101
United States, Ohio
Cincinnati, Ohio, United States, 45246
Dayton, Ohio, United States, 45432
United States, Texas
Corsicana, Texas, United States, 75110
San Antonio, Texas, United States, 78215
United States, Utah
Clinton, Utah, United States, 84015
United States, Virginia
Charlottesville, Virginia, United States, 22902
Midlothian, Virginia, United States, 23113
United States, Washington
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: May 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by NovaBay Pharmaceuticals, Inc.:
pink eye

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

ClinicalTrials.gov processed this record on August 27, 2015