Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
NCT ID: NCT01877694
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2013-06-30
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Auriclosene Solution 0.3%
Dosed QID for 4 Days
Auriclosene Solution 0.3%
Ophthalmic solution dispensed as drops onto the eye
Auriclosene Vehicle
Dosed QID for 4 days
Auriclosene Vehicle
Ophthalmic Vehicle solution dispensed as drops onto the eye
Interventions
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Auriclosene Solution 0.3%
Ophthalmic solution dispensed as drops onto the eye
Auriclosene Vehicle
Ophthalmic Vehicle solution dispensed as drops onto the eye
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bulbar conjunctival injection
* Conjunctival discharge/exudate
* Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
Exclusion Criteria
* Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment
1 Year
ALL
No
Sponsors
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NovaBay Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David W. Stroman, Ph.D.
Role: STUDY_DIRECTOR
NovaBay Pharmaceuticals, Inc.
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Anaheim, California, United States
Bellflower, California, United States
Glendale, California, United States
Huntington Beach, California, United States
Clearwater, Florida, United States
Woodstock, Georgia, United States
Evansville, Indiana, United States
Newton, Kansas, United States
Whitehouse Station, New Jersey, United States
Huntersville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Corsicana, Texas, United States
San Antonio, Texas, United States
Clinton, Utah, United States
Charlottesville, Virginia, United States
Midlothian, Virginia, United States
Spokane, Washington, United States
Countries
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References
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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.
Other Identifiers
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CL1301
Identifier Type: -
Identifier Source: org_study_id
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