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NCT03244072 Clinical Trial

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

Endophthalmitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03244072
Other study ID # PIND 134134
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 1, 2024
Est. completion date October 2025

Study information
Verified date July 2023
Source Zion Therapeutics, LLC
Contact Jason Ahee, M.D.
Phone 435-862-9865
Email aheejason@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60000
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - visually significant cataracts Exclusion Criteria: - allergy to fluoroquinolones, cobalamin (B12)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Moxifloxacin
Intracameral injection
• Placebo
intracameral injection

Locations
Country Name City State
United States Zion Eye Institute Saint George Utah

Sponsors (1)
Lead Sponsor Collaborator
Jason Ahee, M.D.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT00136344 - Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery N/A
Completed NCT04568213 - Hypochlorous Acid Disinfection Prior to Cataract Surgery Phase 3
Terminated NCT01496794 - Endophthalmitis Cultures N/A
Completed NCT00406913 - Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery N/A
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Recruiting NCT05432336 - Complex Ocular Infection, Optimization of Microbiological Diagnosis
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Recruiting NCT06268561 - Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months
Withdrawn NCT00335231 - Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery N/A
Completed NCT01323868 - Endogenous Endophthalmitis in the Inpatient Setting N/A
Completed NCT03363295 - Evaluation of Macular Changes After Intracameral Moxifloxacin for Prevention of Endophthalmitis Phase 4
Suspended NCT02590523 - Intracameral Antibiotic Safety Study Phase 3
Terminated NCT02770729 - Evaluation of Efficacy and Safety of Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis. Phase 3
Not yet recruiting NCT02324166 - Cefazolin-Lidocaine Combination Solution to Reduce Antibiotic Pain Phase 4
Completed NCT02595359 - Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis Phase 2