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

NCT05162625 | Unknown Phase 2

• 1 other identifier: 52246021.8.0000.5404
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants that develop post-traumatic acute endophthalmitis in each group as assessed by a retina specialist according to clinical exam and ultrasonography findings

  Post-traumatic endophthalmitis incidence rate in each group ( group A: topical moxifloxacin and group B: intravenous cefazolin plus ciprofloxacin)

  Will be considered post-traumatic acute endophthalmitis if the patient evolve the condition until 45 days after open globe injury surgery

Study Arms (2)

Topical Moxifloxacin

ACTIVE COMPARATOR

Pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery.

Drug: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution

Intravenous Cephazolin and Ciprofloxacin

ACTIVE COMPARATOR

Pre-surgical prophylaxis with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, until the surgery.

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

Interventions

Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution DRUG

Topical moxifloxacin 0,5% 01 drop every 3 hours

Topical Moxifloxacin

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

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

Also known as: + Cefazolin

Intravenous Cephazolin and Ciprofloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open globe injury

You may not qualify if:

• Under 18 years old
• Requires intravenous antibiotics for other reasons
• Moxifloxacin allergy
• Imunossupressed patients
• Pregnant women

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

University of Campinas

Campinas, Brazil

RECRUITING

MeSH Terms

Conditions

Endophthalmitis

Interventions

Ophthalmic Solutions; Ciprofloxacin; Cefazolin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Central Study Contacts

Renata Diniz Lemos, MD

CONTACT

+55 (19) 993933379; rdinizlemos@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 17, 2021
• Study Start: December 10, 2021
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

BR (1)