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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. Identifier: NCT01532336
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Adenoviral Conjunctivitis Drug: NVC-422 Solution, 0.3% Drug: NVC-422 Vehicle Solution Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sustained Clinical Cure [ Time Frame: Day 18 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532336

  Hide Study 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
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
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.
Study Director: David Stroman, Ph.D. NovaBay Pharmaceuticals, Inc.

Responsible Party: NovaBay Pharmaceuticals, Inc. Identifier: NCT01532336     History of Changes
Other Study ID Numbers: CL1104
BAYnovation ( Other Identifier: NovaBay )
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: July 2014

Keywords provided by NovaBay Pharmaceuticals, Inc.:

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