Back to resultsSafety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
Primary Purpose
Endophthalmitis
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Moxifloxacin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Endophthalmitis
Eligibility Criteria
Inclusion Criteria:
- visually significant cataracts
Exclusion Criteria:
- allergy to fluoroquinolones
Sites / Locations
- Zion Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment group
Placebo group
Arm Description
Intracameral injection of moxifloxacin solution after cataract surgery
Intracameral injection of placebo after cataract surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03244072
Brief Title
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
Official Title
Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Ahee, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Intracameral injection of moxifloxacin solution after cataract surgery
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Intracameral injection of placebo after cataract surgery
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
active
Intervention Description
Intracameral injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sham
Intervention Description
intracameral injection
Primary Outcome Measure Information:
Title
Endophthalmitis after cataract surgery
Description
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.
Time Frame
Subjects will undergo eye examinations at one day, one week, and one month post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
visually significant cataracts
Exclusion Criteria:
allergy to fluoroquinolones, cobalamin (B12)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Ahee, M.D.
Phone
435-862-9865
Email
aheejason@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Ahee, M.D.
Organizational Affiliation
Zion Therapeutics, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zion Eye Institute
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Ahee, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
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