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

NCT ID: NCT03244072

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2031-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Endophthalmitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment group

Intracameral injection of moxifloxacin solution after cataract surgery

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Intracameral injection

Placebo group

Intracameral injection of placebo after cataract surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intracameral injection

Interventions

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Moxifloxacin

Intracameral injection

Intervention Type DRUG

Placebo

intracameral injection

Intervention Type DRUG

Other Intervention Names

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active sham

Eligibility Criteria

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Inclusion Criteria

* visually significant cataracts

Exclusion Criteria

* allergy to fluoroquinolones, cobalamin (B12)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jason Ahee, M.D.

INDUSTRY

Sponsor Role lead

Responsible Party

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Jason Ahee, M.D.

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jason Ahee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zion Therapeutics, LLC

Locations

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Zion Eye Institute

St. George, Utah, United States

Site Status

Countries

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United States

Central Contacts

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Jason Ahee, M.D.

Role: CONTACT

435-862-9865

Facility Contacts

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Jason Ahee, M.D.

Role: primary

Other Identifiers

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PIND 134134

Identifier Type: -

Identifier Source: org_study_id

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