Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery

NCT03244072 — Phase 2 / Phase 3, Not yet recruiting, 60000 participants, Jason Ahee, M.D.

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Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery

Registry	NCT03244072
Status	Not yet recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	60000 (Estimated)
Sponsor	Jason Ahee, M.D. (Industry)
Conditions	Endophthalmitis
Interventions	Moxifloxacin, Placebo (Drug)
Dates	start 2027-06-01 (estimated), primary completion 2030-10-01 (estimated), completion 2031-10-01 (estimated), first posted 2017-08-09, last updated 2026-09-15
Locations	1 site in United States

-Summary

Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

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+Detailed description

Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment group	Active comparator	Drug: Moxifloxacin	Intracameral injection of moxifloxacin solution after cataract surgery
Placebo group	Placebo comparator	Drug: Placebo	Intracameral injection of placebo after cataract surgery

Moxifloxacin (Drug), also known as active: Intracameral injection
Placebo (Drug), also known as sham: intracameral injection

+Outcome measures

Primary outcomes

Endophthalmitis after cataract surgery [Subjects will undergo eye examinations at one day, one week, and one month post-operatively]: Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.

+Eligibility

Sex: All, ages: 40 Years to any, accepts healthy volunteers

Inclusion Criteria:

* visually significant cataracts

Exclusion Criteria:

* allergy to fluoroquinolones, cobalamin (B12)

+Locations (1)

Facility	City	Country	Status
Zion Eye Institute	St. George, Utah	United States

+Investigators

Jason Ahee, M.D., Principal investigator, Zion Therapeutics, LLC

My Notes

Public

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