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

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

Tracking Information

• First Submitted Date: February 9, 2012
• First Posted Date: February 14, 2012
• Last Update Posted Date: May 28, 2015
• Study Start Date: May 2012
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 16, 2012): Sustained Clinical Cure [ Time Frame: Day 18 ]
• Original Primary Outcome Measures (submitted: February 9, 2012): Sustained Clinical Cure at Follow-up [ Time Frame: Day 18 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
• Official Title: A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

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.

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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Adenoviral Conjunctivitis

Intervention

• Drug: NVC-422 Solution, 0.3%
  NVC-422 Ophthalmic Solution dropped onto the eye
  Other Name: Auriclosene
• Drug: NVC-422 Vehicle Solution
  NVC-422 Vehicle Ophthalmic Solution dropped onto the eye

Study Arms

• Experimental: NVC-422 Solution, 0.3%
  Dosed for 10 days
  Intervention: Drug: NVC-422 Solution, 0.3%
• Placebo Comparator: NVC-422 Vehicle Solution
  Dosed for 10 days
  Intervention: Drug: NVC-422 Vehicle Solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 26, 2015): 500
• Original Estimated Enrollment (submitted: February 9, 2012): 450
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil, India, Sri Lanka, United States

Administrative Information

• NCT Number: NCT01532336
• Other Study ID Numbers: CL1104; BAYnovation ( Other Identifier: NovaBay )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: NovaBay Pharmaceuticals, Inc.
• Study Sponsor: NovaBay Pharmaceuticals, Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: NovaBay Pharmaceuticals, Inc.
• Verification Date: July 2014