Zimoxin for Cataract Surgery Prevention

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

60000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if injecting an antibiotic called moxifloxacin into the eye after cataract surgery can prevent infections. Moxifloxacin is commonly used to prevent infections after cataract surgery. It targets patients who have had cataract surgery and aims to stop bacteria from causing infections.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Moxifloxacin for preventing complications after cataract surgery?

Research shows that Moxifloxacin, when used as a preventive measure during eye surgeries, can help reduce the risk of infections like endophthalmitis (a severe eye infection) after procedures such as cataract surgery. ^{1 2 3 4 5}

Is moxifloxacin safe for use in cataract surgery?

Moxifloxacin, used in cataract surgery, has been shown to be safe when injected into the eye, with studies reporting no significant adverse effects and no cases of serious eye infections like endophthalmitis. ^{2 3 6 7 8}

How is the drug moxifloxacin unique for preventing complications in cataract surgery?

Moxifloxacin is unique because it can be used as an intracameral (inside the eye) antibiotic to prevent infections like endophthalmitis after cataract surgery, offering a direct and potentially more effective approach compared to other antibiotics that are applied topically or injected around the eye. ^{2 4 5 8 9}

Research Team

Jason Ahee, M.D.

Principal Investigator

Zion Therapeutics, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

The Effectiveness of Intracameral Moxifloxacin Endophthalmitis Prophylaxis for Trabeculectomy. [2021]

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

Safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution in cataract surgery patients. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Intracameral moxifloxacin after cataract surgery: a prospective study. [2018]

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

Safety of intracameral moxifloxacin in the pediatric population: an equivalence study. [2021]

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

Topical prophylaxis with moxifloxacin prevents endophthalmitis in a rabbit model. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of undiluted intracameral moxifloxacin without postoperative topical antibiotics in cataract surgery. [2018]

7. Brazil pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intracameral moxifloxacin injection for prophylaxis of endophthalmitis after phacoemulsification. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

[Intracameral moxifloxacin: a safe option for endophthalmitis prophylaxis? In vitro safety profile for intraocular application]. [2021]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Epithelial wound healing after cataract surgery comparing two different topical fluoroquinolones. [2021]