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NCT Number: NCT01532336

Efficacy and Safety of NVC-422 in 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.

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Key information

Conditions

Adenoviral Conjunctivitis Adenoviridae Infections Conjunctival Diseases Conjunctivitis DNA Virus Infections Eye Diseases Infections Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Recife, Pernambuco, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NVC-422 Solution, 0.3%

Drug

NVC-422 Ophthalmic Solution dropped onto the eye

Other names: Auriclosene

NVC-422 Vehicle Solution

Drug

NVC-422 Vehicle Ophthalmic Solution dropped onto the eye

Primary outcomes

  1. Sustained Clinical Cure

    Time frame: Day 18

Sponsors and collaborators

Lead sponsor

NovaBay Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

Acronym: BAYnovation™

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2012
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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