Clinical trial NCT01877694: Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Conjunctivitis
Keywords: pink eye
Lead sponsor: NovaBay Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 217
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Microbiological Success
timeFrame: 5 days
Secondary outcomes:
measure: Clinical Cure
timeFrame: 5 days
Other outcomes:
measure: Resolution of individual ocular signs and symptoms
timeFrame: 5 days
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Bellflower
country: United States
state: California
city: Glendale
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Woodstock
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: Newton
country: United States
state: Kansas
city: Whitehouse Station
country: United States
state: New Jersey
city: Huntersville
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Corsicana
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: NovaBay Pharmaceuticals, Inc.
name: David W. Stroman, Ph.D.
role: STUDY_DIRECTOR
References:
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.