Zimoxin for Cataract Surgery Prevention

Not yet recruiting at 1 trial location

Overseen By Jason Ahee, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Jason Ahee, M.D.

Must not be taking: Fluoroquinolones

Disqualifiers: Allergy to fluoroquinolones, cobalamin

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment to prevent eye infections after cataract surgery. It uses moxifloxacin, an antibiotic, injected into the eye to prevent endophthalmitis, a serious infection. Participants will receive either the moxifloxacin injection or a placebo after surgery. Individuals with vision-impairing cataracts and no allergies to certain antibiotics, such as fluoroquinolones or vitamin B12, may be suitable for this trial. As a Phase 2, Phase 3 trial, the research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to advance medical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that applying moxifloxacin directly in the eye after cataract surgery is safe. Studies have found that this antibiotic does not cause harmful side effects when used in recommended amounts. For instance, one study found that a 0.5% moxifloxacin injection during eye surgery was safe and helped reduce the risk of infection. Overall, evidence suggests that moxifloxacin is well-tolerated, making it a promising choice for preventing eye infections after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for preventing infections after cataract surgery, which typically involves topical antibiotic drops, the use of moxifloxacin in this treatment is unique because it is delivered through an intracameral injection directly into the eye. This method ensures a higher concentration of the antibiotic at the surgical site, potentially reducing the risk of post-surgery infections more effectively. Researchers are excited about this approach because it could simplify the post-operative regimen for patients, eliminating the need for multiple eye drop doses and improving overall compliance.

What evidence suggests that moxifloxacin is effective for preventing endophthalmitis after cataract surgery?

Research has shown that using moxifloxacin directly in the eye helps prevent endophthalmitis, an eye infection, after cataract surgery. In this trial, participants in the treatment group will receive an intracameral injection of moxifloxacin solution post-surgery. Studies have found that this treatment greatly lowers the risk of infection and is both safe and effective. This method surpasses other infection prevention techniques after surgery. Overall, the evidence strongly supports using moxifloxacin to protect the eye following cataract surgery. ^{1 5 6 7 8}

Who Is on the Research Team?

Jason Ahee, M.D.

Principal Investigator

Zion Therapeutics, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with visually significant cataracts who are undergoing surgery. It's not suitable for those allergic to fluoroquinolones or cobalamin (B12).

Inclusion Criteria

I have cataracts that affect my vision significantly.

Exclusion Criteria

cobalamin (B12)

You are allergic to fluoroquinolones, a type of medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with post-operative eye examinations

4 weeks

3 visits (in-person) at one day, one week, and one month post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Moxifloxacin

Trial Overview The study tests the safety and effectiveness of an eye injection called Zimoxin, which contains moxifloxacin, to prevent infection after cataract surgery compared to a placebo.

How Is the Trial Designed?

Group I: Treatment group Active Control 1 Intervention

Intracameral injection of moxifloxacin solution after cataract surgery

Group II: Placebo group Placebo Group 1 Intervention

Intracameral injection of placebo after cataract surgery

Moxifloxacin is already approved in United States, European Union for the following indications:

Approved in United States as Moxifloxacin for:

• Acute bacterial sinusitis
• Acute bacterial exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Uncomplicated skin and skin structure infections
• Complicated intra-abdominal infections

Approved in European Union as Moxifloxacin for:

• Acute bacterial sinusitis
• Acute exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Uncomplicated skin and soft tissue infections
• Complicated intra-abdominal infections

Who Is Running the Clinical Trial?

Jason Ahee, M.D.

Lead Sponsor

Trials

1

Recruited

60,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK581595/

Evidence Brief: Intracameral Moxifloxacin for Prevention of ... The current data is strongly suggestive of the superior efficacy of intracameral moxifloxacin for the prevention of endophthalmitis following cataract surgery.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2950253525000723

Effectiveness of intracameral antibiotics in reducing ... Intracameral antibiotic prophylaxis significantly reduces the risk of postoperative endophthalmitis following cataract surgery, with moxifloxacin and vancomycin ...

3. journals.lww.com journals.lww.com/jcrs/abstract/9900/efficacy_of_intracameral_moxifloxacin_in.712.aspx

Efficacy of Intracameral Moxifloxacin in Prevention of Post Intracameral moxifloxacin is safe and effective in preventing post-cataract surgery acute bacterial endophthalmitis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7468651/

The Anterior Chamber Injection of Moxifloxacin Injection to ... An anterior chamber injection of moxifloxacin can effectively prevent the incidence of endophthalmitis after cataract surgery.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02770729

Evaluation of Efficacy and Safety of Intracameral ... Three studies (all respective) found that the intracameral use of moxifloxacin is safe and effective for preventing endophthalmitis following cataract surgery; ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0886335018309672

Safety and efficacy of intracameral moxifloxacin for ... The IC injection of undiluted 0.5% moxifloxacin can be safely applied as the last step of phacoemulsification. It was found to be effective in reducing the risk ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02595359

NCT02595359 | Intracameral Moxifloxacin for Prevention of ... The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract ...

8. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/moxifloxacin-brief.cfm

Evidence Brief - Intracameral Moxifloxacin for Prevention of ... Intracameral moxifloxacin also appears to be safe at the dosages and preparations reported, with no studies reporting adverse events directly ...