Clinical trial NCT01532336: Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
Official title: A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenoviral Conjunctivitis
Keywords: adenovirus
conjunctivitis
pinkeye
Lead sponsor: NovaBay Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 500
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 clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc).

Subjects will be randomly assigned to receive either NVC-422 or Vehicle.

Detailed description: This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle").

Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits:

* Visit 1: Screening, Day 1
* Visit 2: Day 3
* Visit 3: Day 6
* Visit 4: Day 11 End of Treatment (EOT)
* Visit 5: Day 18 Test-of-Cure (TOC)
* Visit 6: Day 42 Follow-up

Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.

Eligibility criteria: Inclusion Criteria:

* Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
* Bulbar conjunctival injection
* Other inclusion criteria per protocol

Exclusion Criteria:

* Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye
* A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation
* Other exclusion criteria per protocol

Primary outcomes:
measure: Sustained Clinical Cure
timeFrame: Day 18
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Petaluma
country: United States
state: California
city: San Diego
country: United States
state: California
city: Fort Myers
country: United States
state: Florida
city: Jacksonville Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Kailua
country: United States
state: Hawaii
city: Glenview
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Shawnee Mission
country: United States
state: Kansas
city: Hazard
country: United States
state: Kentucky
city: Winchester
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Hicksville
country: United States
state: New York
city: Rockville Centre
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Recife
country: Brazil
state: PE
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Joinville
country: Brazil
state: SC
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
city: Hyderabad
country: India
state: Andhra Pradesh
city: Hyderabad
country: India
state: Andhra Pradesh
city: Ahmadabad
country: India
state: Gujarat
city: Surat
country: India
state: Gujarat
city: Bangalore
country: India
state: Karnataka
city: Bangalore
country: India
state: Karnataka
city: Thiruvanathapuram
country: India
state: Kerala
city: Mumbai
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Daryaganj
country: India
state: New Dehli
city: Bikaner
country: India
state: Rajasthan
city: Jaipur
country: India
state: Rajasthan
city: Jaipur
country: India
state: Rajasthan
city: Chennai
country: India
state: Tamil Nadu
city: Salem
country: India
state: Tamil Nadu
city: Kolkata
country: India
state: West Bengal
city: New Dehli
country: India
city: Vishakhapatnam
country: India
city: Colombo
country: Sri Lanka
city: Colombo
country: Sri Lanka
city: Colombo
country: Sri Lanka
city: Kalubowila
country: Sri Lanka
city: Negombo
country: Sri Lanka
city: Nugegoda
country: Sri Lanka
Study officials:
affiliation: NovaBay Pharmaceuticals, Inc.
name: David Stroman, Ph.D.
role: STUDY_DIRECTOR
References: