Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis

Overview

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.

Full Title of Study: “A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2014

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Sustained Clinical Cure
    • Time Frame: Day 18

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NovaBay Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Stroman, Ph.D., Study Director, NovaBay Pharmaceuticals, Inc.

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