Evidence map›Paper›PMID 36564576›Full record

Trial reportEye (London, England)2023

Topical cyclosporine A cationic ophthalmic emulsion in paediatric vernal keratoconjunctivitis: pooled analysis of randomised NOVATIVE and VEKTIS trials.

Andrea Leonardi, Serge Doan, Pasquale Aragona, Mourad Amrane, Dahlia Ismail, Jesús Montero, János Németh, Dominique Bremond-Gignac

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Eye (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT00328653 phase2 / phase3completednot on this map

Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1% Ophthalmic Cationic Emulsion) Versus Vehicle in Patients With VKC

TypeinterventionalSponsorSanten SASRan2006Enrolled118ConditionsConjunctivitis, VernalArmsCyclosporine NOVA22007 0.05%, Cyclosporine NOVA22007 0.1%, Vehicle
NCT01751126 phase3completednot on this map

A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

TypeinterventionalSponsorSanten SASRan2013 to 2016Enrolled169ConditionsVernal KeratoconjunctivitisArmsNOVA22007 ''Ciclosporin'', Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
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

8 authors at 7 institutions in 4 countries.

Andrea LeonardiDepartment of Neuroscience, Ophthalmology Unit, University of Padua, Padua, Italy. andrea.leonardi@unipd.it.ORCID 0000-0002-7246-8580
Serge DoanBichat Hospital and Foundation A. de Rothschild, Paris, France.
Pasquale AragonaDepartment of Biomedical Sciences, Ophthalmology Clinic, University of Messina, Messina, Italy.
Mourad AmraneSanten SAS, Evry, France.
Dahlia IsmailSanten SAS, Evry, France.
Jesús MonteroUniversidad de Sevilla, Seville, Spain.
János NémethDepartment of Ophthalmology, Semmelweis University, Budapest, Hungary.ORCID 0000-0001-8575-4888
Dominique Bremond-GignacDepartment of Ophthalmology, University Hospital Necker Enfants Malades, APHP, Paris, France.
Santen (France) · FRFondation de Rothschild · FRInserm · FRSemmelweis University · HUUniversidad de Sevilla · ESUniversity of Messina · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesCyclosporine A cationic ophthalmic emulsion (CsA CE) was evaluated in paediatric and adolescent patients with vernal keratoconjunctivitis (VKC) in the NOVATIVE (NCT00328653) and VEKTIS (NCT01751126) trials. The similarity of these studies permitted pooled assessment of the effect of CsA CE on corneal damage as well as safety and tolerability. SUBJECTS/

methodsPooled outcomes were assessed for the first 28 days of treatment. In NOVATIVE, 118 patients were randomised to 4 times daily (QID) CsA CE 0.05%, 0.1%, or vehicle eye drops. In VEKTIS, 169 patients were randomised to CsA CE 0.1% QID or twice daily (BID) or vehicle. For these analyses, treatment groups comprised: (1) pooled CsA CE 0.1% QID arms (high-dose; n = 96); (2) pooled CsA CE 0.05% QID arm from NOVATIVE and CsA CE 0.1% BID data from VEKTIS (low-dose; n = 93); and (3) pooled vehicle QID arms (vehicle; n = 98).

resultsChanges from baseline to day 28 (mean ± standard deviation) in corneal fluorescein staining (CFS) scores for CsA CE high-dose, low-dose, and vehicle groups were -1.6 ± 1.47 (95% CI: -0.9, -0.1; p = 0.0124 vs vehicle), -1.7 ± 1.39 (95% CI: -1.1, -0.3; p = 0.0015 vs vehicle), and -1.0 ± 1.55, respectively. Adverse events (AEs) of any type were reported in 37.5%, 34.4%, and 37.8% of the high-dose, low-dose, and vehicle groups, respectively. Most were mild or moderate in severity.

conclusionsCsA CE significantly decreased corneal damage and was safe and well tolerated in patients with VKC. These data support CSA CE as a treatment option for the management of VKC.

Indexed as

Conjunctivitis, AllergicCorneal InjuriesDry Eye SyndromesAdolescentChildCyclosporineDouble-Blind MethodEmulsionsHumansImmunosuppressive AgentsOphthalmic SolutionsTreatment OutcomeCyclosporineEmulsionsImmunosuppressive AgentsOphthalmic Solutions

Identifiers

PMID36564576
PMCPMC10366270
OpenAlexW4312129226

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.