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Tests treatment safety and results for Bacterial Conjunctivitis
Official title Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
ClinicalTrials.gov ID: NCT06911424
What this study is testing
What is Fusidic Acid 1%?
Fusidic Acid 1% is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for bacterial conjunctivitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Main
- Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye, confirmed by the presence of purulent or mucopurulent ocular...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Main
- 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)...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Huntington Beach, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Sherman Oaks, California, United States
- Delray Beach, Florida, United States
- Doral, Florida, United States
- Lake Worth, Florida, United States
- Largo, Florida, United States
- Lutz, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Miami Lakes, Florida, United States
- Palm Springs, Florida, United States
- Tampa, Florida, United States
- Union City, Georgia, United States
- Idaho Falls, Idaho, United States
- Orland Park, Illinois, United States
- Columbia, Maryland, United States
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Huntington Beach, California, United States; La Jolla, California, United States; Long Beach, California, United States; Los Angeles, California, United States; Sherman Oaks, California, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.