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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01532336
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 14, 2012
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
Sustained Clinical Cure [ Time Frame: Day 18 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Sustained Clinical Cure at Follow-up [ Time Frame: Day 18 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
Official Title  ICMJE A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adenoviral Conjunctivitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
500
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2012)
450
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   India,   Sri Lanka,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01532336
Other Study ID Numbers  ICMJE CL1104
BAYnovation ( Other Identifier: NovaBay )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NovaBay Pharmaceuticals, Inc.
Study Sponsor  ICMJE NovaBay Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Stroman, Ph.D. NovaBay Pharmaceuticals, Inc.
PRS Account NovaBay Pharmaceuticals, Inc.
Verification Date July 2014

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