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Safety and Efficacy of Topical Moxifloxacin for Prevention of Post-Traumatic Endophthalmitis: Randomized Controlled Clinical Trial

NCT05162625 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-17

No results posted yet for this study

Summary

Open globe injuries (OGI) are among the main causes of blindness or irreversible severe reduction in visual acuity in the world. An estimated 2.3 million people live with bilateral low vision and nearly 19 million live with blindness or unilateral low vision due to such trauma. Pre-surgical prophylaxis to prevent serious infectious complications such as endophthalmitis is frequently performed, however, there are discrepancies in its performance between services as there is no proven superior protocol. Different combinations of antibiotics and administration routes are currently used.

The aim of this study is to evaluate the efficacy and safety of the use of topical moxifloxacin 0.5% ophthalmic solution (Vigamox®) in the prophylaxis of acute endophthalmitis in patients with OGI. This is a prospective, controlled, randomized, single-center study conducted in patients diagnosed with OGI at the Clinical Hospital of São Paulo State University, Campinas.

Volunteers who present OGI and sign the informed consent form (ICF) will be randomized into 2 groups: in group A, volunteers will undergo pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery.

In group B, the volunteers will receive pre-surgical prophylaxis as it is currently done in the service, with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, prior to surgery. Intraoperative and post-surgical care will be the same for both groups and will continue to be carried out in line with the current service protocol. Patients will be followed for 45 days, with a complete ophthalmological evaluation that aims to verify the incidence of endophthalmitis in both groups. It is expected to find an equal or lower incidence of endophthalmitis in the group that received topical administration of moxifloxacin.

Conditions

  • Endophthalmitis
  • Open Globe Injury
  • Moxifloxacin
  • Post-Traumatic Endophthalmitis

Interventions

DRUG

Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution

Topical moxifloxacin 0,5% 01 drop every 3 hours

DRUG

Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]

Intravenous ciprofloxacin 400mg every 12 hours and cefazolin 1000mg every 6 hours

Sponsors & Collaborators

  • University of Campinas, Brazil

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-12-10
Completion
2023-12-10

Countries

  • Brazil

Study Locations

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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 NCT05162625 on ClinicalTrials.gov