- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244072
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
September 21, 2025 updated by: Jason Ahee, M.D.
Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60000
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jason Ahee, M.D.
- Phone Number: 435-862-9865
- Email: aheejason@hotmail.com
Study Locations
-
-
Utah
-
St. George, Utah, United States, 84790
- Zion Eye Institute
-
Contact:
- Jason Ahee, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- visually significant cataracts
Exclusion Criteria:
- allergy to fluoroquinolones, cobalamin (B12)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment group
Intracameral injection of moxifloxacin solution after cataract surgery
|
Intracameral injection
Other Names:
|
|
Placebo Comparator: Placebo group
Intracameral injection of placebo after cataract surgery
|
intracameral injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endophthalmitis after cataract surgery
Time Frame: 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.
|
Subjects will undergo eye examinations at one day, one week, and one month post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason Ahee, M.D., Zion Therapeutics, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2031
Study Registration Dates
First Submitted
August 4, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 9, 2017
Study Record Updates
Last Update Posted (Estimated)
September 25, 2025
Last Update Submitted That Met QC Criteria
September 21, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Eye Infections
- Endophthalmitis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Fluoroquinolones
- 4-Quinolones
- Quinolones
- Quinolines
- Moxifloxacin
- Exercise
- salicylhydroxamic acid
Other Study ID Numbers
- PIND 134134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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