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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 1

Locations

Indonesia

Study Type

Interventional

Intervention

Moxifloxacin Ophthalmic Solution

Levofloxacin Ophthalmic

About this trial

This is an interventional treatment trial for Cataract focused on measuring Moxifloxacin, Levofloxacin, Cataract surgery

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Fakultas Kedokteran Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxifloxacin

Levofloxacin

Arm Description

Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.

Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.

Outcomes

Primary Outcome Measures

Endothelial cell density

Corneal endothelial cell density measured using specular microscopy

Secondary Outcome Measures

Central corneal thickness

Central corneal thickness (in nm) measured using specular microscopy

Central macular thickness

Central macular thickness (in nm) measure using optical coherence tomography

Anterior chamber cell reactions

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.

Intraocular pressure

Intraocular pressure (in mmHg) measured using automated non contact tonometer

Full Information

NCT ID

NCT05741632

First Posted

February 14, 2023

Last Updated

August 18, 2023

Sponsor

Indonesia University

Collaborators

Ferron Par Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05741632

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

Collaborators

Ferron Par Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

Moxifloxacin, Levofloxacin, Cataract surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participant will be masked receiving treatment, post operative eye drops of both arms is the same. Subject allocation is blinded to investigator and outcomes assessor.

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxifloxacin

Arm Type

Experimental

Arm Description

Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.

Arm Title

Levofloxacin

Arm Type

Active Comparator

Arm Description

Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin Ophthalmic Solution

Other Intervention Name(s)

Molcin(R)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Levofloxacin Ophthalmic

Other Intervention Name(s)

Cravit(R)

Intervention Description

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

Primary Outcome Measure Information:

Title

Endothelial cell density

Description

Corneal endothelial cell density measured using specular microscopy

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Central corneal thickness

Description

Central corneal thickness (in nm) measured using specular microscopy

Time Frame

1 month

Title

Central macular thickness

Description

Central macular thickness (in nm) measure using optical coherence tomography

Time Frame

1 month

Title

Anterior chamber cell reactions

Description

Time Frame

1 month

Title

Intraocular pressure

Description

Intraocular pressure (in mmHg) measured using automated non contact tonometer

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arcci Pradessatama, MD

Organizational Affiliation

RSCM Kirana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fakultas Kedokteran Universitas Indonesia

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30691922

Citation

Melega MV, Alves M, Cavalcanti Lira RP, Cardoso da Silva I, Ferreira BG, Assis Filho HL, Pedreira Chaves FR, Martini AAF, Dias Freire LM, Reis RD, Leite Arieta CE. Safety and efficacy of intracameral moxifloxacin for prevention of post-cataract endophthalmitis: Randomized controlled clinical trial. J Cataract Refract Surg. 2019 Mar;45(3):343-350. doi: 10.1016/j.jcrs.2018.10.044. Epub 2019 Jan 25.

Results Reference

background

PubMed Identifier

32050222

Citation

Chang DF, Prajna NV, Szczotka-Flynn LB, Benetz BA, Lass JH, O'Brien RC, Menegay HJ, Gardner S, Shekar M, Rajendrababu S, Rhee DJ. Comparative corneal endothelial cell toxicity of differing intracameral moxifloxacin doses after phacoemulsification. J Cataract Refract Surg. 2020 Mar;46(3):355-359. doi: 10.1097/j.jcrs.0000000000000064.

Results Reference

background

PubMed Identifier

29846429

Citation

Lucena NP, Pereira IMS, Gaete MIL, Ferreira KSA, Melega MV, Lira RPC. Intracameral moxifloxacin after cataract surgery: a prospective study. Arq Bras Oftalmol. 2018 Apr;81(2):92-94. doi: 10.5935/0004-2749.20180022.

Results Reference

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

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