NCT05741632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

February 14, 2023

Last Update Submit

August 18, 2023

Conditions

Cataract

Keywords

MoxifloxacinLevofloxacinCataract surgery

Outcome Measures

Primary Outcomes (1)

  • Endothelial cell density

    Corneal endothelial cell density measured using specular microscopy

    1 month

Secondary Outcomes (4)

  • Central corneal thickness

    1 month

  • Central macular thickness

    1 month

  • Anterior chamber cell reactions

    1 month

  • Intraocular pressure

    1 month

Study Arms (2)

Moxifloxacin

EXPERIMENTAL

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

Drug: Moxifloxacin Ophthalmic Solution

Levofloxacin

ACTIVE COMPARATOR

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

Drug: Levofloxacin Ophthalmic

Interventions

Moxifloxacin Ophthalmic SolutionDRUG

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

Also known as: Molcin(R)
Moxifloxacin
Levofloxacin OphthalmicDRUG

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

Also known as: Cravit(R)
Levofloxacin

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (3)

  • 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.

    PMID: 30691922BACKGROUND

  • 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.

    PMID: 32050222BACKGROUND

  • 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.

    PMID: 29846429BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Arcci Pradessatama, MD

    RSCM Kirana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology Department Resident

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

February 1, 2023

Primary Completion

March 31, 2023

Study Completion

April 1, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)