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

August 18, 2023 updated by: Arcci Pradessatama, Indonesia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to observe the safety profile in patient receiving cataract surgery who receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile defined as visual acuity, intraocular pressure, corneal endothelial cell density, central corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery; (2) receiving undiluted levofloxacin 0.1 cc during surgery.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Fakultas Kedokteran Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Immature senile cataract in one or both eye
  • Agree to be included and signed informed consent

Exclusion Criteria:

  • Have a history of allergy to moxifloxacin or levofloxacin or any other antibiotics
  • Other ocular comorbid such as uveitis, glaucoma, diabetic retinopathy, pseudoexfoliation, and endothelial disorders
  • Ocular surgery prior to study
  • Sign of infection or inflammation around the eye
  • Cataract density more than grade 4 according to Lens Opacities Classification System (LOCS) III grading
  • Corneal endothelial cell density < 1500 cell/ mm2
  • Anterior chamber depth < 2.5 mm
  • Diabetes mellitus type 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moxifloxacin
Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.
Drug: Moxifloxacin Ophthalmic Solution
Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery
Other Names:
  • Molcin(R)
Active Comparator: Levofloxacin
Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.
Drug: Levofloxacin Ophthalmic
Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery
Other Names:
  • Cravit(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell density
Time Frame: 1 month
Corneal endothelial cell density measured using specular microscopy
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central corneal thickness
Time Frame: 1 month
Central corneal thickness (in nm) measured using specular microscopy
1 month
Central macular thickness
Time Frame: 1 month
Central macular thickness (in nm) measure using optical coherence tomography
1 month
Intraocular pressure
Time Frame: 1 month
Intraocular pressure (in mmHg) measured using automated non contact tonometer
1 month
Anterior chamber cell reactions
Time Frame: 1 month
Anterior chamber cell reactions measured in Standardization of Uveitis Nomenclature (SUN) grading. Values consist of 0, trace, 1+, 2+, 3+, and 4+. Higher grading score means more inflammatory reaction which is worse.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Ferron Par Pharmaceuticals

Investigators

  • Principal Investigator: Arcci Pradessatama, MD, RSCM Kirana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-10-1262
  • KET-1303/UN2.F1/ETIK/PPM.00.02 (Other Identifier: Komite Etik Penelitian Kesehatan FKUI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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