Who is sponsoring NCT04212078?

NCT04212078 is sponsored by National University of Malaysia.

What drugs are being tested in NCT04212078?

Interventions in NCT04212078: Levofloxacin Ophthalmic, Cefuroxime.

What condition does NCT04212078 study?

NCT04212078 studies Endophthalmitis Postoperative.

Is NCT04212078 still recruiting?

NCT04212078 is currently status unknown. Last updated 18 September 2020.

Last reviewed 2020-09-18 · How we verify

NCT04212078

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intracameral Levofloxacin (0.5%) Versus Intracameral Cefuroxime (1mg/0.1ml) Effect on Corneal Endothelial Cell Count and Morphology in Uneventful Phacoemulsification

Status unknown Phase 1/Phase 2 Last updated 18 September 2020

What this trial tests

Phase 1/Phase 2 trial testing Levofloxacin Ophthalmic in Endophthalmitis Postoperative in 138 participants. Status unknown.

Timeline

29 July 2019

Primary endpoint
1 January 2022

1 October 2022

Quick facts

Lead sponsor	National University of Malaysia
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	138
Start date	29 July 2019
Primary completion	1 January 2022
Estimated completion	1 October 2022
Sites	1 location across Malaysia

Drugs / interventions tested

Levofloxacin Ophthalmic — full drug profile →
Cefuroxime (CEFUROXIME) — full drug profile →

Conditions studied

Endophthalmitis Postoperative — all drugs for Endophthalmitis Postoperative →

Sponsor

National University of Malaysia

Who can join

Adults 50 to 80, any sex, with Endophthalmitis Postoperative. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-week post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-month post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 3-month post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-week post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-month post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 3-month post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.

Sponsor's own description

Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Exogenous spread usually happens post intraocular surgery or procedure (i.e. cataract, vitrectomy, glaucoma filtration surgery) while endogenous spread is associated with hematogenous spread. The occurrence of endophthalmitis accounts for serious post-operative complication which can lead to severe vision loss and even blindness. There are several studies conducted to ascertain the efficiency of intracameral antibiotic as post-operative endophthalmitis prophylaxis. However, there is limited study in human using intracameral levofloxacin to evaluate its effect.This study is designed to compare between intracameral levofloxacin and intracameral cefuroxime in terms of corneal endothelial cell count and its morphology and central corneal thickness in uncomplicated phacoemulsification surgery

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Levofloxacin Ophthalmic

Trials testing the same drug.

NCT05741632 — Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery · Phase 1 · completed
NCT04403334 — Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin · Phase 4 · completed

Other National University of Malaysia trials

Trials by the same sponsor.

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NCT07157397 — Effect of a Plant-Focused Diet on Nutritional Status in Malnourished Peritoneal Dialysis Patients · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04212078 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National University of Malaysia
Last refreshed: 18 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04212078.

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