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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
Primary Completion Date : May 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

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

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
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

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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