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

Bacterial Conjunctivitis Clinical Trial

— BACTOvation™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877694
• Other study ID #: CL1301
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2013
• Last updated: May 26, 2015
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: NovaBay Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Auriclosene Solution 0.3%
Ophthalmic solution dispensed as drops onto the eye
• Auriclosene Vehicle
Ophthalmic Vehicle solution dispensed as drops onto the eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NovaBay Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resolution of individual ocular signs and symptoms		5 days	No
Primary	Microbiological Success	Eradication of all pre-therapy isolates	5 days	No
Secondary	Clinical Cure	Resolution of all signs and symptoms	5 days	No