Evidence map›Paper›PMID 35567735›Full record

ArticleOphthalmology and therapy2022

Effects of a New Formulation of Multiple-Action Tear Substitute on Objective Ocular Surface Parameters and Ocular Discomfort Symptoms in Patients with Dry Eye Disease.

Luca Vigo, Carlotta Senni, Marco Pellegrini, Aldo Vagge, Lorenzo Ferro Desideri, Francesco Carones, Vincenzo Scorcia, Giuseppe Giannaccare

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06478134 (Efficacy and Safety of a Multiple-Action Tear Substitute), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
4.0field-weighted citation impact, top 6% 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.

NCT06478134 phase2 / phase3completednot on this mapstarted 2023, after this paper: background citation

Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease: A Randomized, Double-blinded, HA-controlled Study

TypeinterventionalSponsorUniversity of SevilleRan2023 to 2024Enrolled124ConditionsDry EyeArmsTrimix tear substitutes, Hyaluronic acid tear substitute
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 21 citations in OpenAlex.

  1. 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.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Trial
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  15. Recent progress of nanomedicine in managing dry eye disease.Advances in ophthalmology practice and research
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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 4 institutions in 1 country.

Luca Vigo *Carones Ophthalmology Center, Via Domodossola 19, 20145, Milan, Italy.
Carlotta SenniDepartment of Ophthalmology, University Vita-Salute-IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
Marco PellegriniDepartment of Translational Medicine, University of Ferrara, Via Savonarola 9, 44121, Ferrara, Italy.
Aldo VaggeEye Clinic of Genoa, Policlinico San Martino, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genova, Via Balbi 5, 16126, Genoa, Italy.
Lorenzo Ferro DesideriEye Clinic of Genoa, Policlinico San Martino, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genova, Via Balbi 5, 16126, Genoa, Italy.
Francesco CaronesCarones Ophthalmology Center, Via Domodossola 19, 20145, Milan, Italy.
Vincenzo ScorciaDepartment of Ophthalmology, University "Magna Græcia" of Catanzaro, Viale Europa, 88100, Catanzaro, Italy.
Giuseppe Giannaccare *Department of Ophthalmology, University "Magna Græcia" of Catanzaro, Viale Europa, 88100, Catanzaro, Italy. giuseppe.giannaccare@unicz.it.ORCID http://orcid.org/0000-0003-2617-0289
Magna Graecia University · ITOspedale Policlinico San Martino · ITIRCCS Ospedale San Raffaele · ITUniversity of Ferrara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRecently, there has been a progressive shift from simple water-adding medications towards complex multi-action combined formulas aimed at disrupting different mechanisms within the dry eye disease (DED) vicious cycle. This study evaluated the efficacy and tolerability of Trimix eye drops (Off Health Italia, Italy), a combination of viscosity-enhancing hyaluronic acid, trehalose, and cationic liposomes comprising stearylamine and phospholipids, in patients with DED.

methodsIn this prospective, pilot study patients diagnosed with mild to moderate DED were enrolled and treated with Trimix eye drops three times daily for 2 months. Ocular surface workup was performed before (V0) and after therapy (V1) by means of IDRA (SBM Sistemi, Turin, Italy), for the measurement of (i) noninvasive break-up time (NIBUT); (ii) tear meniscus height (TMH); (iii) lipid layer thickness (LLT); (iv) infrared meibography (percentage of meibomian gland loss); (v) bulbar redness (Efron scale). Treatment tolerability was scored on a visual analog scale ranging from 0 (none/not at all) to 100 (much/very) for eight questions. Ocular discomfort symptoms were scored using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire.

resultsOverall, 25 subjects (mean age 60.32 ± 14.55 years) were included in the study. At V1, TMH, NIBUT, and LLT significantly increased compared to V0 (from 0.29 ± 0.06 to 0.46 ± 0.06 mm, 6.34 ± 2.61 to 7.58 ± 2.52 s, and from 63.26 ± 17.15 to 68.42 ± 15.63 nm, respectively; all P < 0.04). Concerning ocular discomfort symptoms, SPEED score significantly improved at V1 (from 16.63 ± 6.32 to 8.30 ± 5.98; P < 0.001); moreover, treatment tolerability was high for all eight items investigated.

conclusionsTwo-month treatment with Trimix formulation improved objective signs and subjective symptoms in patients with DED, showing also a good tolerability profile.

Indexed as

DEDDry eye diseaseMATSMultiple-action tear substituteTrimix

Identifiers

PMID35567735
PMCPMC9253225
OpenAlexW4280573397

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.