Evidence map›Paper›PMID 39386177›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2024

Alleviation of Allergic Rhinoconjunctivitis Symptoms in Participants Treated with a 0.005% Tacrolimus Eye-Drop Solution.

Svenja Sladek, Nicole Unger-Manhart, Cornelia Siegl, Hanna Dellago, Petra U Zieglmayer, Patrick Lemell, Markus Savli, René Zieglmayer, Wolfgang Geitzenauer, Matthias Längauer and 1 more

Registry-linked trialAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04532710 (Clinical Evaluation of Two Different Dosage Groups of Tacrosolv Eye Drops in a Placebo Controlled Crossover Design to Evaluate Safety and Efficacy in Patients Suffering From Grass Pollen Induced Allergic Rhinoconjunctivitis in the Vienna Challenge Chamber.), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT04532710 phase2completednot on this map

Clinical Evaluation of Two Different Dosage Groups of Tacrosolv Eye Drops in a Placebo Controlled Crossover Design to Evaluate Safety and Efficacy in Patients Suffering From Grass Pollen Induced Allergic Rhinoconjunctivitis in the Vienna Challenge Chamber.

TypeinterventionalSponsorMarinomed Biotech AGRan2020 to 2021Enrolled64ConditionsAllergic Conjunctivitis, Allergic RhinitisArmsEye Drops, Solution in Single-Dose Container
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

11 authors.

Svenja SladekMarinomed Biotech AG, Korneuburg, Austria.
Nicole Unger-ManhartMarinomed Biotech AG, Korneuburg, Austria.
Cornelia SieglMarinomed Biotech AG, Korneuburg, Austria.
Hanna DellagoMarinomed Biotech AG, Korneuburg, Austria.
Petra U ZieglmayerCompetence Center for Allergology and Immunology, Department of General Health Studies, Karl Landsteiner Private University for Health Sciences, Krems, Austria.ORCID 0000-0001-5432-9459
Patrick LemellPower Project GmbH, Vienna Challenge Chamber, Vienna, Austria.
Markus SavliBiostatistik & Consulting GmbH, Zuerich, Switzerland.
René ZieglmayerPower Project GmbH, Vienna Challenge Chamber, Vienna, Austria.
Wolfgang GeitzenauerKrankenhaus der Barmherzigen Brüder, St. John Hospital, Department of Ophthalmology, Vienna, Austria.
Matthias LängauerKrankenhaus der Barmherzigen Brüder, St. John Hospital, Department of Ophthalmology, Vienna, Austria.ORCID 0009-0003-4279-2405
Eva Prieschl-GrassauerMarinomed Biotech AG, Korneuburg, Austria.ORCID 0000-0003-0118-4297

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This randomized, placebo-controlled, crossover, double-blind trial aimed to evaluate the efficacy and safety of Tacrosolv, a novel 0.005% tacrolimus eye-drop solution, in adults with grass pollen-induced allergic conjunctivitis. Methods: A total of 64 adult participants were randomized to receive 2.5 µg or 5 µg tacrolimus/eye/day or placebo treatment for 8 days, with grass pollen exposure on day 1 and day 8. After a 2-week washout period, placebo participants crossed over to Tacrosolv treatment and vice versa, with repeated treatment and exposure. During exposure, participants recorded ocular, nasal, and respiratory allergy symptoms every 15 minutes. The primary endpoint was the mean total ocular symptom score (TOSS) on day 8. Objective ocular safety parameters were assessed before, during, and after exposure. Adverse events were recorded throughout the study. Results: On day 8, high-dose Tacrosolv reduced the TOSS compared to placebo towards the end of exposure ( Conclusion: High-dose Tacrosolv is safe and effective for alleviating symptoms of allergic rhinoconjunctivitis. Trial Registration: NCT04532710; EudraCT No. 2019-002847-62.

Indexed as

allergic rhinoconjunctivitisclinical trialocular itchingocular rednesstacrolimustopical administration

Identifiers

PMID39386177
PMCPMC11463181

What OpenQuestion holds

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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.