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

NovaBay Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Bacterial Conjunctivitis

Treatments: Drug: Auriclosene Vehicle; Drug: Auriclosene Solution 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01877694

CL1301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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217 participants in 2 patient groups, including a placebo group

Auriclosene Solution 0.3%

Experimental group

Description:

Dosed QID for 4 Days

Treatment:

Drug: Auriclosene Solution 0.3%

Auriclosene Vehicle

Placebo Comparator group

Description:

Dosed QID for 4 days

Treatment:

Drug: Auriclosene Vehicle