Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
BACTOvation™
A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis
1 other identifier
interventional
217
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2013
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMay 28, 2015
May 1, 2015
1.5 years
June 7, 2013
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microbiological Success
Eradication of all pre-therapy isolates
5 days
Secondary Outcomes (1)
Clinical Cure
5 days
Other Outcomes (1)
Resolution of individual ocular signs and symptoms
5 days
Study Arms (2)
Auriclosene Solution 0.3%
EXPERIMENTALDosed QID for 4 Days
Auriclosene Vehicle
PLACEBO COMPARATORDosed QID for 4 days
Interventions
Ophthalmic solution dispensed as drops onto the eye
Ophthalmic Vehicle solution dispensed as drops onto the eye
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Birmingham, Alabama, 35244, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Anaheim, California, 92804, United States
Unknown Facility
Bellflower, California, 90706, United States
Unknown Facility
Glendale, California, 91204, United States
Unknown Facility
Huntington Beach, California, 92647, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
Woodstock, Georgia, 30189, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Newton, Kansas, 67114, United States
Unknown Facility
Whitehouse Station, New Jersey, 08889, United States
Unknown Facility
Huntersville, North Carolina, 28078, United States
Unknown Facility
Winston-Salem, North Carolina, 27101, United States
Unknown Facility
Cincinnati, Ohio, 45246, United States
Unknown Facility
Dayton, Ohio, 45432, United States
Unknown Facility
Corsicana, Texas, 75110, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Clinton, Utah, 84015, United States
Unknown Facility
Charlottesville, Virginia, 22902, United States
Unknown Facility
Midlothian, Virginia, 23113, United States
Unknown Facility
Spokane, Washington, 99202, United States
Related Publications (1)
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.
PMID: 29602567DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David W. Stroman, Ph.D.
NovaBay Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 14, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
May 28, 2015
Record last verified: 2015-05