Evidence map›Paper›PMID 32285142›Full record

Trial reportEuropean journal of clinical pharmacology2020

Aqueous humour concentrations after topical apPlication of combinEd levofloxacin-dexamethasone eye dRops and of its single components: a randoMised, assEssor-blinded, parallel-group study in patients undergoing cataract surgery: the iPERME study.

Michele Figus, Chiara Posarelli, Dario Romano, Marco Nardi, Luca Rossetti

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03740659 (Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03740659 phase2completednot on this map

Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME

TypeinterventionalSponsorNTC srlRan2018 to 2018Enrolled125ConditionsCataractArmsLevofloxacin + Dexamethasone, Levofloxacin, Dexamethasone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Michele FigusDepartment of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, Via Paradisa, 2, 56100, Pisa, Italy. michele.figus@unipi.it.
Chiara PosarelliDepartment of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, Via Paradisa, 2, 56100, Pisa, Italy.
Dario RomanoEye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan, Italy.
Marco NardiDepartment of Surgical, Medical, Molecular Pathology and of Critical Area, University of Pisa, Via Paradisa, 2, 56100, Pisa, Italy.
Luca RossettiEye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan, Italy.
University of Pisa · ITUniversity of Milan · IT

Funding

NTC srl, Milan - Italy EUDRA CT code: 2018-001149-15.
6 · The paper itself

Abstract

purposeTo evaluate the penetration of levofloxacin and dexamethasone sodium phosphate into the aqueous humour (AH) after administration in combination and as single molecules. Evaluation of the penetration of those agents in the site of action and their pharmacodynamic potential activity in view of the intended clinical use after cataract surgery.

methodsRandomised, assessor-blinded, parallel-group. Patients scheduled for cataract surgery were assigned in a 1:1:1 ratio to: levofloxacin + dexamethasone sodium phosphate (L-DSP), Levofloxacin (L) or Dexamethasone sodium phosphate (DSP) eye drops. Either test or reference drugs were instilled in the cul-de-sac twice, 90 and 60 min before paracentesis.

resultsA total of 125 patients completed the study. Fraction of dose absorbed in the anterior chamber was 3.8-4.2 · 10

conclusionOur results confirm that no interaction is evident on the corneal penetration of levofloxacin and dexamethasone which reach pharmacologically active concentrations when instilled as fixed combination eye drops to patients undergoing cataract surgery.

trial registrationClinicalTrials.gov Identifier: NCT03740659.

Indexed as

Administration, TopicalAgedAged, 80 and overAnti-Bacterial AgentsAnti-Inflammatory AgentsAqueous HumorCataract ExtractionCorneaDexamethasoneDrug CombinationsFemaleHumansLevofloxacinMaleMiddle AgedOphthalmic SolutionsAnti-Bacterial AgentsAnti-Inflammatory AgentsDexamethasoneDrug CombinationsLevofloxacinOphthalmic SolutionsAqueous humourCombination eye dropDexamethasoneLevofloxacin

Identifiers

PMID32285142
PMCPMC7306033
OpenAlexW3015615510

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.