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

Sponsor
Jason Ahee, M.D. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03244072
Collaborator
(none)
15,000
Enrollment
1
Location
2
Arms
33
Anticipated Duration (Months)
454.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment group

Intracameral injection of moxifloxacin solution after cataract surgery

Drug: Moxifloxacin
Intracameral injection
Other Names:
  • active

    		•
    Placebo Comparator: Placebo group

    Intracameral injection of placebo after cataract surgery

    Drug: Placebo
    intracameral injection
    Other Names:
  • sham

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • visually significant cataracts
    Exclusion Criteria:
    • allergy to fluoroquinolones

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zion Eye Institute Saint George Utah United States 84790

    Sponsors and Collaborators

    • Jason Ahee, M.D.

    Investigators

    • Principal Investigator: Jason Ahee, M.D., Zion Therapeutics, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason Ahee, M.D., Medical Director, Zion Therapeutics, LLC
    ClinicalTrials.gov Identifier:
    NCT03244072
    Other Study ID Numbers:
    • PIND 134134
    First Posted:
    Aug 9, 2017
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endophthalmitis
    Cataract
    Capsule Opacification
    Moxifloxacin

    Study Results

    No Results Posted as of Aug 23, 2022