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
  Purpose

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.


Condition Intervention Phase
Adenoviral Conjunctivitis
Drug: NVC-422 Ophthalmic Solution, 0.33%
Drug: Vehicle Ophthalmic Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

Resource links provided by NLM:


Further study details as provided by NovaBay Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Sustained Clinical Cure [ Time Frame: Day 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVC-422 Ophthalmic Solution, 0.33%
Dosed for 10 days
Drug: NVC-422 Ophthalmic Solution, 0.33%
Placebo Comparator: Vehicle Ophthalmic Solution
Dosed for 10 days
Drug: Vehicle Ophthalmic Solution

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532336

  Show 58 Study Locations
Sponsors and Collaborators
NovaBay Pharmaceuticals, Inc.
Investigators
Study Director: David Stroman, Ph.D. NovaBay Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01532336     History of Changes
Other Study ID Numbers: CL1104, BAYnovation
Study First Received: February 9, 2012
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
India: Drugs Controller General of India
Sri Lanka: Cosmetics Devices & Drugs Regulatory Authority

Keywords provided by NovaBay Pharmaceuticals, Inc.:
adenovirus
conjunctivitis
pinkeye

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Inclusion
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection

ClinicalTrials.gov processed this record on April 21, 2014