Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01532336
First received: February 9, 2012
Last updated: March 26, 2014
Last verified: March 2014

February 9, 2012
March 26, 2014
May 2012
April 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 adenoviral conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either NVC-422 or Vehicle. Six visits will be required for this study.

Not Provided
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 Ophthalmic Solution, 0.33%
  • Drug: Vehicle Ophthalmic Solution
  • Experimental: NVC-422 Ophthalmic Solution, 0.33%
    Dosed for 10 days
    Intervention: Drug: NVC-422 Ophthalmic Solution, 0.33%
  • Placebo Comparator: Vehicle Ophthalmic Solution
    Dosed for 10 days
    Intervention: Drug: Vehicle Ophthalmic Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
June 2014
April 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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   India,   Sri Lanka
 
NCT01532336
CL1104, BAYnovation
No
NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals, Inc.
Not Provided
Study Director: David Stroman, Ph.D. NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals, Inc.
March 2014

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