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OpenTrials
Completed

NCT Number: NCT01877694

Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis

The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.

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Key information

Conditions

Bacterial Conjunctivitis Bacterial Infections Bacterial Infections and Mycoses Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Eye Diseases Eye Infections Eye Infections, Bacterial Infections

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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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: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").

Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:

  • Visit 1: Screening, Day 1
  • Visit 2: Day 3 (±1)
  • Visit 3: Day 5 (+1) Test of Cure/Exit

IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.

Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1 year of age and older
  • Bulbar conjunctival injection
  • Conjunctival discharge/exudate
  • Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
  • Other inclusion criteria per protocol

Exclusion criteria

  • Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis
  • Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment
  • Other exclusion criteria per protocol

Treatment and study plan

Auriclosene Solution 0.3%

Drug

Ophthalmic solution dispensed as drops onto the eye

Other names: NVC-422

Auriclosene Vehicle

Drug

Ophthalmic Vehicle solution dispensed as drops onto the eye

Primary outcomes

  1. Microbiological Success

    Time frame: 5 days

    Eradication of all pre-therapy isolates

Secondary outcomes

  1. Clinical Cure

    Time frame: 5 days

    Resolution of all signs and symptoms

Other outcomes

  1. Resolution of individual ocular signs and symptoms

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

NovaBay Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis

Acronym: BACTOvation™

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 14, 2013
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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