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Intracameral Antibiotic Safety Study

Phase 3
Waitlist Available
Research Sponsored by Panhandle Eye Group, LLP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Pivotal Trial

Summary

The goal of this study is to determine the safety (but not efficacy in preventing infection) of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin at certain dosages and concentrations as prepared by a compounding pharmacy when used intracamerally at the time of cataract surgery.

Eligible Conditions
  • Endophthalmitis
  • Intracameral Antibiotics
  • Cataract Surgery
  • Vancomycin
  • Moxifloxacin

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Postoperative visual acuity measured by best spectacle corrected
Other study objectives
Endothelial cell count measured by specular microscopy

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: B: MoxifloxacinExperimental Treatment1 Intervention
Intracameral moxifloxacin injection given at conclusion of cataract case
Group II: A: VancomycinExperimental Treatment1 Intervention
Intracameral vancomycin injection given at conclusion of cataract case
Group III: C: PlaceboPlacebo Group1 Intervention
Intracameral placebo injection with BSS given at conclusion of cataract case
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2020
Completed Phase 4
~7920
Moxifloxacin
2013
Completed Phase 4
~3290

Find a Location

Who is running the clinical trial?

Panhandle Eye Group, LLPLead Sponsor
2 Previous Clinical Trials
718 Total Patients Enrolled
~171 spots leftby Dec 2025
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