Evidence map›Paper›PMID 36523849›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2022

Topical Omega-3 Polyunsaturated Fatty Acids for the Treatment of Dry Eye - Results from a Pilot Randomized Controlled Masked-Observer Study.

Thomas Kaercher, Elisabeth M Messmer, Thomas Berninger, Klaudia K Huber-van der Velden, Raphaela Geiger, Pauline Cipriano-Bonvin, Christina Jacobi

Open access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Article
  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

7 authors at 5 institutions in 2 countries.

Thomas KaercherAugenarztpraxis, Heidelberg, Germany.ORCID 0000-0003-3472-1319
Elisabeth M MessmerDepartment of Ophthalmology, Ludwig-Maximilian-University, Munich, Germany.
Thomas BerningerAugenzentrum, Olching, Germany.
Klaudia K Huber-van der VeldenAugenheilkunde Lindenthal, Köln-Lindenthal, Germany.
Raphaela GeigerTRB Chemedica AG, Feldkirchen, Germany.
Pauline Cipriano-BonvinTRB Chemedica International SA, Geneva, Switzerland.
Christina JacobiAugen & Haut Zentrum-Praxis Dr. Jacobi, Nuremberg, Germany.ORCID 0000-0001-9382-4399
Augenklinik Heidelberg · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEKrankenhaus Lindenbrunn · DEOrthopädische Praxis · DETRB Chemedica International (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To investigate the efficacy, safety and tolerability of topical omega-3 polyunsaturated fatty acids (PUFA) as an innovative treatment of dry eye disease (DED). Patients and Methods: In a pilot, multicenter, masked-observer, randomized, active-controlled, non-inferiority study in Germany, patients self-treated their eyes with daily instillations of eye drops containing either omega-3 PUFA or povidone as major components for three months. At four and twelve weeks, efficacy was among others evaluated based on Ocular Surface Disease Index (OSDI), ocular surface symptoms intensity, general clinical impression, tear break-up time (TBUT), corneal fluorescein staining using the Oxford grading scale, tear volume, and matrix metalloproteinase-9 (MMP-9) concentration in the tear film. Safety evaluation included visual acuity, intraocular pressure, and the incidence of adverse events. Co-primary endpoints were the mean percent changes from baseline of TBUT and OSDI after four weeks. Results: In total 80 patients were included, of whom 37 in the PUFA group and 39 in the povidone group were evaluable for the co-primary endpoints. Patients had a mean age of 52 years and >80% were women. Both co-primary endpoints (TBUT and OSDI) significantly improved from baseline in both treatment groups, at Week 4 and Week 12 and the statistical analysis demonstrated topical omega-3 PUFA to be non-inferior to 2% povidone for these two parameters. Both treatments resulted in a significant improvement of most secondary efficacy endpoints as well, often with a slight difference in favor of PUFA, not reaching statistical significance though. One non-severe, treatment-related local AE was reported in each group. Conclusion: Omega-3 PUFA-based eye drops proved to be non-inferior to povidone-containing eye drops in the treatment of signs and symptoms of dry eye. This treatment may thus be an additional tool for the management of DED.

Indexed as

artificial tearsdry eye diseaseomega-3 fatty acidpolyunsaturated fatty acidspovidone

Identifiers

PMID36523849
PMCPMC9744874
OpenAlexW4310807238

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.