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

May 26, 2015 updated by: NovaBay Pharmaceuticals, Inc.

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PE
      • Recife, PE, Brazil, 50070-040
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
    • SC
      • Joinville, SC, Brazil, 89201-010
    • SP
      • Sao Paulo, SP, Brazil, 01221-020
      • Sao Paulo, SP, Brazil, 04023-062
      • Sao Paulo, SP, Brazil, 04502-001
      • Sorocaba, SP, Brazil, 18031-060
  • India
      • New Dehli, India, 110 608
      • Vishakhapatnam, India, 530 013
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 034
      • Hyderabad, Andhra Pradesh, India, 500 096
    • Gujarat
      • Ahmadabad, Gujarat, India, 380 016
      • Surat, Gujarat, India, 395 001
    • Karnataka
      • Bangalore, Karnataka, India, 560 010
      • Bangalore, Karnataka, India, 560 054
    • Kerala
      • Thiruvanathapuram, Kerala, India, 695 011
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 004
      • Mumbai, Maharashtra, India, 400 020
      • Mumbai, Maharashtra, India, 400 080
      • Mumbai, Maharashtra, India, 400 602
    • New Dehli
      • Daryaganj, New Dehli, India, 110 002
    • Rajasthan
      • Bikaner, Rajasthan, India, 334 001
      • Jaipur, Rajasthan, India, 302 004
      • Jaipur, Rajasthan, India, 302 015
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 010
      • Salem, Tamil Nadu, India, 636 004
    • West Bengal
      • Kolkata, West Bengal, India, 700 073
  • 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
  • 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
    • Florida
      • Fort Myers, Florida, United States, 33901
      • Jacksonville Beach, Florida, United States, 32250
      • Tampa, Florida, United States, 33603
    • Georgia
      • Albany, Georgia, United States, 31701
    • Hawaii
      • Kailua, Hawaii, United States, 96734
    • Illinois
      • Glenview, Illinois, United States, 60026
      • Peoria, Illinois, United States, 61615
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
    • Kentucky
      • Hazard, Kentucky, United States, 41701
    • Massachusetts
      • Winchester, Massachusetts, United States, 01890
    • Missouri
      • Kansas City, Missouri, United States, 64154
      • St. Louis, Missouri, United States, 63131
    • New York
      • Hicksville, New York, United States, 11801
      • Rockville Centre, New York, United States, 11570
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • High Point, North Carolina, United States, 27262
      • Winston-Salem, North Carolina, United States, 27101
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
    • South Carolina
      • Charleston, South Carolina, United States, 29414
      • Spartanburg, South Carolina, United States, 29306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained Clinical Cure
Time Frame: Day 18
Day 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovaBay Pharmaceuticals, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1104
  • BAYnovation (Other Identifier: NovaBay)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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