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

Primary Purpose

Bacterial Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Auriclosene Solution 0.3%
Auriclosene Vehicle
Sponsored by
NovaBay Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring pink eye

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Auriclosene Solution 0.3%

Auriclosene Vehicle

Arm Description

Dosed QID for 4 Days

Dosed QID for 4 days

Outcomes

Primary Outcome Measures

Microbiological Success
Eradication of all pre-therapy isolates

Secondary Outcome Measures

Clinical Cure
Resolution of all signs and symptoms

Full Information

First Posted
June 7, 2013
Last Updated
May 26, 2015
Sponsor
NovaBay Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01877694
Brief Title
Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
Acronym
BACTOvation™
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovaBay Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
Keywords
pink eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auriclosene Solution 0.3%
Arm Type
Experimental
Arm Description
Dosed QID for 4 Days
Arm Title
Auriclosene Vehicle
Arm Type
Placebo Comparator
Arm Description
Dosed QID for 4 days
Intervention Type
Drug
Intervention Name(s)
Auriclosene Solution 0.3%
Other Intervention Name(s)
NVC-422
Intervention Description
Ophthalmic solution dispensed as drops onto the eye
Intervention Type
Drug
Intervention Name(s)
Auriclosene Vehicle
Intervention Description
Ophthalmic Vehicle solution dispensed as drops onto the eye
Primary Outcome Measure Information:
Title
Microbiological Success
Description
Eradication of all pre-therapy isolates
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Clinical Cure
Description
Resolution of all signs and symptoms
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
Resolution of individual ocular signs and symptoms
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W. Stroman, Ph.D.
Organizational Affiliation
NovaBay Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Whitehouse Station
State/Province
New Jersey
ZIP/Postal Code
08889
Country
United States
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23113
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29602567
Citation
Lee CS, Lee AY, Akileswaran L, Stroman D, Najafi-Tagol K, Kleiboeker S, Chodosh J, Magaret A, Wald A, Van Gelder RN; BAYnovation Study Group. Determinants of Outcomes of Adenoviral Keratoconjunctivitis. Ophthalmology. 2018 Sep;125(9):1344-1353. doi: 10.1016/j.ophtha.2018.02.016. Epub 2018 Mar 27.
Results Reference
derived

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

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