Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis (BAYnovation™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01532336
First received: February 9, 2012
Last updated: May 26, 2015
Last verified: July 2014

February 9, 2012
May 26, 2015
May 2012
May 2014   (final data collection date for primary outcome measure)
Sustained Clinical Cure [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
Sustained Clinical Cure at Follow-up [ Time Frame: Day 18 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01532336 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Adenoviral Conjunctivitis
  • Drug: NVC-422 Solution, 0.3%
    NVC-422 Ophthalmic Solution dropped onto the eye
    Other Name: Auriclosene
  • Drug: NVC-422 Vehicle Solution
    NVC-422 Vehicle Ophthalmic Solution dropped onto the eye
  • Experimental: NVC-422 Solution, 0.3%
    Dosed for 10 days
    Intervention: Drug: NVC-422 Solution, 0.3%
  • Placebo Comparator: NVC-422 Vehicle Solution
    Dosed for 10 days
    Intervention: Drug: NVC-422 Vehicle Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
August 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
1 Year and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   India,   Sri Lanka
 
NCT01532336
CL1104, BAYnovation
No
Not Provided
Not Provided
NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals, Inc.
Not Provided
Study Director: David Stroman, Ph.D. NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP