Evidence map›Paper›PMID 39560701›Full record

ArticleOphthalmology and therapy2025

Evaluation of the Performance of an Ocular Surface Modulator Containing ST-Lysyal Versus Hyaluronic Acid Eyedrops in Patients with Dry Eye Disease: A Pilot Study.

Stefano Barabino, Andrea Rosa, Sara Marini, Carlo Domenico Bianchi, Maurizio Rolando

Abstract read
In one paragraph

Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

1 citing paper in PubMed.

  1. 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

5 authors.

Stefano BarabinoOcular Surface and Dry Eye Center, ASST Fatebenefratelli-Sacco, Milan University, Milan, Italy. stefano.barabino@asst-fbf-sacco.it.
Andrea RosaOphthalmology Department, ASST Fatebenefratelli-Sacco, Milan University, Milan, Italy.
Sara MariniOphthalmology Department, ASST Fatebenefratelli-Sacco, Milan University, Milan, Italy.
Carlo Domenico BianchiOphthalmology Department, ASST Fatebenefratelli-Sacco, Milan University, Milan, Italy.
Maurizio RolandoOcular Surface & Dry Eye Center, Is.PRE Oftalmica, Genoa, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDry eye disease (DED) is a multifactorial condition of the ocular surface, primarily treated with tear substitutes, which do not fully restore natural tear functions. In this pilot study, we tested the hypothesis that T-Lysyal (T-Lys) improves symptoms and signs in patients with DED. Additionally, we provide a literature overview on the effects of T-Lys in ophthalmology and non-ophthalmology conditions to elucidate its mechanisms of action.

methodsA double-masked, randomized pilot study was conducted in patients with DED treated with T-Lys or hyaluronic acid (HA) 0.2% combined with tamarind seeds polysaccharide (control group) for 2 months. Inclusion criteria were a diagnosis of DED with symptoms lasting ≥ 6 months, Symptom Assessment in Dry Eye (SANDE) score ≥ 30, and at least one of the following: fluorescein staining of the cornea (score ≥ 3, NEI scale), conjunctival staining (Lissamine Green, score ≥ 3), or tear breakup time (T-BUT) ≤ 10 s. Data from the right eye were used for statistical analysis. A PubMed literature search of T-Lys studies was also performed without publication year restrictions.

resultsTwelve patients in the T-Lys group and 15 in the control group completed the study (mean age 67 ± 11 years). T-Lys treatment resulted in significant improvements from baseline (V0) to 2 months (V2) in symptoms assessed by visual analogue scale (T-Lys: 4.58 ± 2.57 mm at V0, 2.92 ± 1.38 mm at V2, p < 0.05; control: 5.13 ± 2.29 mm at V0, 5.3 ± 2.4 mm at V2), T-BUT (T-Lys: 2.58 ± 1.31 s at V0, 3.58 ± 1.37 s at V2, p < 0.05; control: 3.07 ± 1.43 s at V0, 3 ± 1.13 s at V2), and corneal staining (T-Lys: 2.16 ± 4.17 at V0, 1.41 ± 3.70 at V2, p < 0.05; control: 1.4 ± 2.19 at V0, 1.4 ± 2.16 at V2). No adverse events were reported. Literature findings supported T-Lys's efficacy in managing both ophthalmology and non-ophthalmology conditions.

conclusionThis study provides the first clinical evidence of T-Lys efficacy in patients with DED, supporting preclinical data and highlighting its potential as a promising ocular surface modulator.

trial registrationThe study was registered in the ISRCTN registry for Clinical Studies with no. 13587929.

Indexed as

Dry eye diseaseEyedropsHyaluronic acidsT-LysyalTear substitutesT-Lys

Identifiers

PMID39560701
PMCPMC11724810

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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.