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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Fusidic Acid 1% 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 chloramphenicol in some studies. It is well tolerated with fewer side effects, making it a good option for treating eye infections. ^{1 2 3 4 5}

Is fusidic acid safe for treating pink eye?

Fusidic acid has been used safely for many years, with minor side effects like stomach discomfort and headaches. In studies for eye infections, it was well tolerated with no serious side effects reported. ^{1 2 6 7 8}

How does the drug fusidic acid differ from other treatments for pink eye?

Fusidic acid is unique because it is a potent antibiotic that can be administered as a viscous eye drop, allowing for sustained release and effective treatment with just twice-daily dosing. It has a lower resistance rate compared to other antibiotics like chloramphenicol, making it more effective against common bacteria causing pink eye. ^{1 2 3 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

References

1. Germany pubmed.ncbi.nlm.nih.gov

Fusidic acid in infections of the external eye. [2019]

2. Denmark pubmed.ncbi.nlm.nih.gov

Fusidic acid in acute conjunctivitis. Single-blind, randomized comparison of fusidic acid and chloramphenicol viscous eye drops. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Fusidic acid in other infections. [2020]

4. Denmark pubmed.ncbi.nlm.nih.gov

Fucithalmic in acute conjunctivitis. Open, randomized comparison of fusidic acid, chloramphenicol and framycetin eye drops. [2019]

5. England pubmed.ncbi.nlm.nih.gov

What type of eye drops should be given to a toddler with conjunctivitis? [2013]

6. United States pubmed.ncbi.nlm.nih.gov

The safety record of fusidic acid in non-US markets: a focus on skin infections. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Fusidic acid pharmacology, pharmacokinetics and pharmacodynamics. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Fusidic acid adverse drug reactions. [2019]

9. France pubmed.ncbi.nlm.nih.gov

Fusidic acid in tear fluid: pharmacokinetic study with fusidic acid viscous eye drops. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Corneal and intraocular penetration of topical and subconjunctival fusidic acid. [2019]