NCT03244072

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for phase_2

Timeline
65mo left

Started Jun 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Oct 2031

First Submitted

Initial submission to the registry

August 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
8.8 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

September 25, 2025

Status Verified

August 1, 2025

Enrollment Period

4.3 years

First QC Date

August 4, 2017

Last Update Submit

September 21, 2025

Conditions

Endophthalmitis

Outcome Measures

Primary Outcomes (1)

  • Endophthalmitis after cataract surgery

    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.

    Subjects will undergo eye examinations at one day, one week, and one month post-operatively

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Intracameral injection of moxifloxacin solution after cataract surgery

Drug: Moxifloxacin

Placebo group

PLACEBO COMPARATOR

Intracameral injection of placebo after cataract surgery

Drug: Placebo

Interventions

MoxifloxacinDRUG

Intracameral injection

Also known as: active
Treatment group
PlaceboDRUG

intracameral injection

Also known as: sham
Placebo group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • visually significant cataracts

You may not qualify if:

  • allergy to fluoroquinolones, cobalamin (B12)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zion Eye Institute

St. George, Utah, 84790, United States

Location

MeSH Terms

Conditions

Endophthalmitis

Interventions

MoxifloxacinExercisesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jason Ahee, M.D.

    Zion Therapeutics, LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Ahee, M.D.

CONTACT

435-862-9865aheejason@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 9, 2017

Study Start

June 1, 2026

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2031

Last Updated

September 25, 2025

Record last verified: 2025-08

Locations

US(1)