Bacterial Conjunctivitis
Conditions
Keywords
pink eye
Brief 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.
Detailed 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.
Interventions
DRUGAuriclosene Solution 0.3%
Ophthalmic solution dispensed as drops onto the eye
DRUGAuriclosene Vehicle
Ophthalmic Vehicle solution dispensed as drops onto the eye
Sponsors
NovaBay Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Success | 5 days | Eradication of all pre-therapy isolates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | 5 days | Resolution of all signs and symptoms |
Other
| Measure | Time frame |
|---|---|
| Resolution of individual ocular signs and symptoms | 5 days |
Countries
United States
Outcome results
None listed