Fusidic Acid for Pink Eye

Recruiting at 25 trial locations

Overseen By Director of Clinical Operations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Baxis Pharmaceuticals, Inc.

Must not be taking: Non-study ocular, systemic

Disqualifiers: Fungal, Protozoal, Viral, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 week

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop treatment called fusidic acid to determine if it is more effective than a placebo (an inactive look-alike treatment) for bacterial conjunctivitis, also known as pink eye. The goal is to confirm that fusidic acid is both effective and safe for use in the eyes. Suitable candidates for this trial have bacterial conjunctivitis with noticeable discharge or redness and have not recently used other eye treatments. Participants will use either the fusidic acid drops or a placebo twice a day for one week. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any non-study eye medications or certain systemic medications before starting the trial.

Is there any evidence suggesting that fusidic acid 1% is likely to be safe for humans?

Research has shown that fusidic acid 1% eye drops are generally safe and well-tolerated. In past studies, most participants did not experience serious side effects. The treatment is intended for short-term use, typically seven days, and successfully relieved symptoms for many users. The risk of overuse is low due to the small amount of active ingredients in the drops. However, prolonged use can lead to bacterial resistance, so it's important to follow the recommended duration. Additionally, wearing contact lenses while using the drops is not advisable. Overall, fusidic acid 1% is considered safe when used as directed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pink eye?

Most treatments for pink eye (conjunctivitis) rely on broad-spectrum antibiotics or antihistamines to reduce symptoms. But fusidic acid 1% offers something new by specifically targeting bacterial protein synthesis, making it particularly effective against certain bacteria responsible for the infection. This targeted action may reduce the risk of resistance developing compared to broader antibiotics. Additionally, fusidic acid is known for its good ocular penetration, potentially leading to quicker symptom relief. Researchers are excited about fusidic acid because it could provide a more efficient and focused treatment option for bacterial pink eye.

What evidence suggests that fusidic acid 1% might be an effective treatment for pink eye?

Studies have shown that fusidic acid 1% effectively treats bacterial conjunctivitis, commonly known as pink eye. In this trial, participants will receive either fusidic acid 1% or a placebo. After 7 days of using fusidic acid, 76% of patients cleared their infection, compared to only 41% who received a placebo, a substance with no active medicine. Another study found fusidic acid successful in 85% of children, outperforming another common treatment. These results demonstrate that fusidic acid effectively clears infections and reduces the symptoms of pink eye. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults and children with bacterial conjunctivitis, who haven't used other eye treatments in the last 14 days. Participants must not wear contacts or eye makeup during the study, test negative for viral conjunctivitis, and use contraception if sexually active. Pregnant or breastfeeding individuals, recent participants in other trials, those allergic to study drugs, or with certain ocular conditions are excluded.

Inclusion Criteria

Agree to discontinue use of contact lenses during study participation

Have a negative viral conjunctivitis test in both eyes

Be willing and able to provide informed consent and comply with the study requirements

Exclusion Criteria

Have participated in another clinical trial ≤30 days or received another experimental drug ≤90 days prior to Visit 1

Have a known intolerance, sensitivity or allergy to the study medications or any of their components

Have a family member or household member enrolled in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive fusidic acid 1% or placebo eye drops twice a day for 7 days

1 week

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fusidic Acid 1%

Trial Overview The trial tests whether Fusidic Acid 1% is more effective than a placebo in treating bacterial conjunctivitis when applied topically to the eyes. It aims to confirm its safety profile and requires participants to have at least mild redness according to a specific redness scale.

How Is the Trial Designed?

Group I: Fusidic Acid 1% Experimental Treatment 1 Intervention

Participants will instill one drop of fusidic acid 1% per eye twice a day (BID) for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing

Group II: Placebo Placebo Group 1 Intervention

Participants will instill one drop of Placebo ophthalmic solution per eye BID for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing

Who Is Running the Clinical Trial?

Baxis Pharmaceuticals, Inc.

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1570507/

The treatment of acute infectious conjunctivitis with fusidic ... After 7 days, the bacterial eradication rates were 16/21 (76%) in the treatment group and 12/29 (41%) in the placebo group with a risk difference of 34.8% (95% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06911424?term=FUSIDIC%20ACID&rank=3

Efficacy of Fusidic Acid 1% in the Treatment of Bacterial ... The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial ...

3. withpower.com withpower.com/trial/phase-3-conjunctivitis-bacterial-2-2025-10430

Fusidic Acid for Pink Eye Research shows that Fusidic Acid 1% is effective in treating bacterial conjunctivitis (pink eye) with a high success rate, outperforming other treatments like ...

4. cda-amc.ca cda-amc.ca/sites/default/files/pdf/htis/feb-2013/RC0430%20Fucidic%20Acid%20Draft%20Final.pdf

Fusidic Acid for Ophthalmic Infections: A Review of Clinical ... Short term (seven day) treatment with topical fusidic acid resolved clinical signs and symptoms of conjunctivitis or chronic blepharitis in 76% ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/3570479/

Fusidic acid in infections of the external eye The overall clinical success rate in children with bacterial conjunctivitis was 85% with fusidic acid, compared to 48% with chloramphenicol (p less than 0.001).

6. pdf.hres.ca pdf.hres.ca/dpd_pm/00025061.PDF

FUCITHALMIC® FUCITHALMIC is a sterile preparation of viscous eye drops containing fusidic acid 1%. Fusidic acid is an antibiotic which kills bacteria that ...

7. regionvasterbotten.se regionvasterbotten.se/VLL/Filer/Fusidinsyra%20-%20Fucithalmic,%20Amdipharm%20UK%20Limited.pdf

Fusidic Acid 1% Viscous Eye Drops The concentration of the excipients is too low to constitute a safety risk. Therefore, overdose is unlikely to occur.

8. medicines.org.uk medicines.org.uk/emc/files/pil.5188.pdf

Fusidic acid 1% w/w Viscous Eye Drops ... Do not use Fusidic acid Eye drops for a long time as the bacteria may no longer be killed by the antibiotic. • Do not wear any type of contact lenses whilst ...

9. dhpp.hpfb-dgpsa.ca dhpp.hpfb-dgpsa.ca/dhpp/resource/5638/consumer-information

Consumer Information for: FUCIDIN OINTMENT 2% Do not let FUCIDIN® get into your eyes. If the cream or the ointment gets into the eye, this may lead to eye irritation. Tell your healthcare professional about ...