Bacterial Conjunctivitis
Conditions
Keywords
Conjunctival Diseases, Eye Diseases, Eye Infections, Bacterial, Bacterial Infections, Infections, Eye Infections, Conjunctivitis, Bacterial, Conjunctivitis
Brief summary
The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.
Interventions
DRUGFusidic Acid 1%
Fusidic acid 1%
DRUGPlacebo
Placebo ophthalmic solution
Sponsors
Baxis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
All study staff (Sponsor, Site and Contract Research Organization (CRO)) involved in the day to day activities of the study are masked. Each site will have a designated unmasked dosing coordinator and the Sponsor/CRO will have an unmasked team member(s) as well, who is not involved in study conduct (e.g., for investigational product or statistical activities that require an unmasked individual).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye, confirmed by the presence of purulent or mucopurulent ocular discharge and a grade ≥ 1 on the modified Validated Bulbar Redness (VBR) conjunctival redness scale. * Have not received any ocular treatment for conjunctivitis, aside from eyelid hygiene, ≤14 days prior to Visit 1. * Have a negative viral conjunctivitis test in both eyes. * Agree to discontinue use of eye/eyelid cosmetics during study participation. * Agree to discontinue use of contact lenses during study participation. * Be willing and able to provide informed consent and comply with the study requirements. * Not be currently pregnant or breastfeeding. If sexually active, agree to use approved contraception for the duration of the study. Main
Exclusion criteria
* Have signs and/or symptoms or a diagnosis of fungal, protozoal, or viral etiology ≤30 days prior to Visit 1. * Have experienced signs and symptoms of bacterial conjunctivitis for \>48 hours prior to Visit 1. * Require or are expected to require use of any non-study topical ocular medication or systemic medications prior to Visit 1 as specified in the protocol as ineligible. * Have any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible. * Have a known intolerance, sensitivity or allergy to the study medications or any of their components. * Have participated in another clinical trial ≤30 days or received another experimental drug ≤90 days prior to Visit 1. * Have a family member or household member enrolled in this study. * Have a condition which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study. * Be an employee of or immediate family member of an employee (directly related to study conduct) at the study site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | Visit 2 (Day 4) | Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbial Eradication | Visit 2 (Day 4) | Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication. |
| Clinical Cure | Visit 3 (Day 8) | Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure. |
Countries
United States
Contacts
CONTACTDirector of Clinical Operations
Outcome results
None listed