Evidence map›Paper›PMID 39934351›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2025

Efficacy and safety of a multi-action tear substitute based on 0.15% cross-linked hyaluronic acid, 3% trehalose and liposomes with stearylamine: A randomized, single-mask, controlled study.

Antonio Ballesteros-Sánchez, Giovanni Roberto Tedesco, Carlos Rocha-de-Lossada, Fedele Russo, José-María Sánchez-González, Davide Borroni

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

6 authors.

Antonio Ballesteros-SánchezDepartment of Optics and Optometry, Universitat Politècnica de Catalunya, 08222, Terrassa, Spain. antonio.ballesteros@upc.edu.ORCID http://orcid.org/0000-0002-9248-8685
Giovanni Roberto TedescoCentro Oculistico Tedesco, 88024, Girifaldo, Italy.
Carlos Rocha-de-LossadaQvision, Ophthalmology Department, VITHAS Almeria Hospital, 04120, Almeria, Spain.
Fedele RussoCentro oculistico Russo, 339 castrovillari, Castrovillari, Italy.
José-María Sánchez-GonzálezDepartment of Physics of Condensed Matter, Optics Area, University of Seville, 41004, Seville, Spain.
Davide BorroniRiga Stradins University, LV-1007, Riga, Latvia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the efficacy and safety of TriMix, a new multiple-action tear substitute in patients with dry eye disease (DED).

methodsThis was a randomized, multicenter, single-masked, hyaluronic acid (HA)-controlled clinical trial conducted between July, 2023 and May, 2024. A total of 115 patients were randomly allocated to receive either TriMix tear substitute or 0.15% HA tear substitute 3 times daily. Clinical outcomes include ocular surface disease index (OSDI) questionnaire, non-invasive tear film break-up time (NIBUT) and Schirmer I test (ST) without anesthesia at 3 and 6 months of follow-up.

resultsOf the 115 patients randomized, 80 completed the study (TriMix, n = 56; HA, n = 24). At months 3 and 6, improvements from baseline were statistically greater with TriMix tear substitute compared to HA 0.15% tear substitute for OSDI: -3.7 points (95% CI, -6.9 to -0.6; p = 0.011) and - 7.5 points (95% CI, -10.3 to -4.6; p < 0.001), respectively. Similar results were reported for NIBUT: 0.9 s (95% CI, 0.3 to 1.6; P = 0.040) and 1.6 s (95% CI, 0.7 to 2.6; P < 0.001), respectively. Regarding safety, no serious ocular adverse events occurred. Three patients complained of burning after instillation of TriMix tear substitute.

conclusionThis RCTs demonstrate that TriMix tear substitute provides statistically significant and clinically evidence of the reduction of DED symptoms with a satisfactory safety profile through 6 months of follow-up. Findings suggest the use of this tear substitute, but results should be confirmed independently over longer time periods.

Indexed as

Dry Eye SyndromesHyaluronic AcidLubricant Eye DropsTearsAdultAgedFemaleFollow-Up StudiesHumansLiposomesMaleMiddle AgedSingle-Blind MethodTreatment OutcomeHyaluronic AcidLiposomesLubricant Eye DropsCationic liposomes.Hyaluronic acidMultiple-action tear substituteTrehaloseTrimix

Identifiers

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Registered trials

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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.