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
  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 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.


Condition Intervention Phase
Adenoviral Conjunctivitis
Drug: NVC-422 Solution, 0.3%
Drug: NVC-422 Vehicle 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 ]

Enrollment: 500
Study Start Date: May 2012
Study Completion Date: August 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVC-422 Solution, 0.3%
Dosed for 10 days
Drug: NVC-422 Solution, 0.3%
NVC-422 Ophthalmic Solution dropped onto the eye
Other Name: Auriclosene
Placebo Comparator: NVC-422 Vehicle Solution
Dosed for 10 days
Drug: NVC-422 Vehicle Solution
NVC-422 Vehicle Ophthalmic Solution dropped onto the eye

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

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532336

  Hide Study Locations
Locations
United States, California
Glendale, California, United States, 91205
Los Angeles, California, United States, 90048
Petaluma, California, United States, 94954
San Diego, California, United States, 92115
United States, Florida
Fort Myers, Florida, United States, 33901
Jacksonville Beach, Florida, United States, 32250
Tampa, Florida, United States, 33603
United States, Georgia
Albany, Georgia, United States, 31701
United States, Hawaii
Kailua, Hawaii, United States, 96734
United States, Illinois
Glenview, Illinois, United States, 60026
Peoria, Illinois, United States, 61615
United States, Kansas
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Hazard, Kentucky, United States, 41701
United States, Massachusetts
Winchester, Massachusetts, United States, 01890
United States, Missouri
Kansas City, Missouri, United States, 64154
St. Louis, Missouri, United States, 63131
United States, New York
Hicksville, New York, United States, 11801
Rockville Centre, New York, United States, 11570
United States, North Carolina
Asheville, North Carolina, United States, 28803
High Point, North Carolina, United States, 27262
Winston-Salem, North Carolina, United States, 27101
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Charleston, South Carolina, United States, 29414
Spartanburg, South Carolina, United States, 29306
Brazil
Recife, PE, Brazil, 50070-040
Rio de Janeiro, RJ, Brazil, 21941-913
Porto Alegre, RS, Brazil, 90035-903
Joinville, SC, Brazil, 89201-010
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 04023-062
Sao Paulo, SP, Brazil, 04502-001
Sorocaba, SP, Brazil, 18031-060
India
Hyderabad, Andhra Pradesh, India, 500 034
Hyderabad, Andhra Pradesh, India, 500 096
Ahmadabad, Gujarat, India, 380 016
Surat, Gujarat, India, 395 001
Bangalore, Karnataka, India, 560 010
Bangalore, Karnataka, India, 560 054
Thiruvanathapuram, Kerala, India, 695 011
Mumbai, Maharashtra, India, 400 004
Mumbai, Maharashtra, India, 400 020
Mumbai, Maharashtra, India, 400 080
Mumbai, Maharashtra, India, 400 602
Daryaganj, New Dehli, India, 110 002
Bikaner, Rajasthan, India, 334 001
Jaipur, Rajasthan, India, 302 004
Jaipur, Rajasthan, India, 302 015
Chennai, Tamil Nadu, India, 600 010
Salem, Tamil Nadu, India, 636 004
Kolkata, West Bengal, India, 700 073
New Dehli, India, 110 608
Vishakhapatnam, India, 530 013
Sri Lanka
Colombo, Sri Lanka, 01000
Colombo, Sri Lanka, 11010
Colombo, Sri Lanka
Kalubowila, Sri Lanka, 10350
Negombo, Sri Lanka, 11500
Nugegoda, Sri Lanka, 10250
Sponsors and Collaborators
NovaBay Pharmaceuticals, Inc.
Investigators
Study Director: David Stroman, Ph.D. NovaBay Pharmaceuticals, Inc.
  More Information

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: May 26, 2015
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
India: Drugs Controller General of India
Sri Lanka: Medical Technology & Supplies Sub-Committee on Clinical Trials

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
Pharmaceutical Solutions
Ophthalmic Solutions

ClinicalTrials.gov processed this record on July 27, 2016