MedTrace Logo

Intracameral Antibiotic Safety Study

NCT02590523 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-04-27

No results posted yet for this study

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.

Conditions

  • Intracameral Antibiotics
  • Cataract Surgery
  • Phacoemulsification
  • Endophthalmitis
  • Vancomycin
  • Moxifloxacin

Interventions

DRUG

Vancomycin

Intracameral vancomycin injection during cataract surgery

DRUG

Moxifloxacin

Intracameral moxifloxacin injection during cataract surgery

DRUG

Placebo

Intracameral placebo injection with BSS during cataract surgery

Sponsors & Collaborators

  • Panhandle Eye Group, LLP

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590523 on ClinicalTrials.gov