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Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery

NCT05741632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-08-22

No results posted yet for this study

Summary

The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile.

Participant will be randomized into two treatment arms. All participant will receive standardized treatment before, during, and after surgery and will be followed up at one day, one week, and one month after surgery.

Conditions

  • Cataract

Interventions

DRUG

Moxifloxacin Ophthalmic Solution

Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

DRUG

Levofloxacin Ophthalmic

Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

Sponsors & Collaborators

  • Ferron Par Pharmaceuticals

    collaborator UNKNOWN

  • Indonesia University

    lead OTHER

Principal Investigators

  • Arcci Pradessatama, MD · RSCM Kirana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-03-31
Completion
2023-04-01

Countries

  • Indonesia

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 NCT05741632 on ClinicalTrials.gov