Evidence map›Paper›PMID 39432158›Full record

ArticleOphthalmology and therapy2024

A Preservative-Free Combination of Sodium Hyaluronate and Trehalose Improves Dry Eye Signs and Symptoms and Increases Patient Satisfaction in Real-Life Settings: The TEARS Study.

Antonio J Mateo-Orobia, Sarah Farrant, Eduardo Del-Prado-Sanz, Alejandro Blasco-Martínez, Miriam Idoipe-Corta, Noelia Lafuente-Ojeda, Luis E Pablo-Júlvez

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04803240 (Survey), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04803240 completednot on this map

Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

TypeobservationalSponsorLaboratoires TheaRan2019 to 2020Enrolled310ConditionsDry EyeArmsThealoz Duo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Antonio J Mateo-OrobiaHospital Universitario Miguel Servet, Zaragoza, Spain. catarata@comz.org.ORCID http://orcid.org/0000-0002-3167-0061
Sarah FarrantEarlam and Christopher Optometrists Ltd, Taunton, TA1 1TW, UK.
Eduardo Del-Prado-SanzHospital Royo Villanova, Spain, Zaragoza.
Alejandro Blasco-MartínezHospital Nuestra Señora de Gracia, Zaragoza, Spain.
Miriam Idoipe-CortaHospital Universitario Miguel Servet, Zaragoza, Spain.
Noelia Lafuente-OjedaHospital Universitario Miguel Servet, Zaragoza, Spain.
Luis E Pablo-JúlvezHospital Universitario Miguel Servet, Zaragoza, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDry eye disease (DED) is a frequently observed condition characterized by ocular discomfort and visual disturbance. It is highly prevalent and impairs patients' quality of life (QoL). This study assessed the benefit of a preservative-free bioprotectant eye drop formulation containing sodium hyaluronate and trehalose (SH-trehalose) with regards to DED, as well as patient satisfaction, through a large-scale real-life survey.

methodsIn a multi-center, international, prospective observational study, subjects with DED received SH-trehalose for 84 days. Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire-5 items (DEQ-5), and patient satisfaction were assessed at baseline, day 28, and day 84, and clinical evaluations included ocular surface staining, Schirmer test, tear film break-up time (TBUT), and conjunctival hyperemia at baseline and day 84.

resultsA total of 312 patients were evaluated, of whom 82.4% were women. The mean age was 57.9 ± 15.2 years. The mean OSDI score at baseline was 41.7 ± 20.6. After 84 days, the mean OSDI score was 27.3 ± 19.8 (p < 0.001). The percentage of patients with a severe OSDI score decreased from 60.3 to 34.5%. The DEQ-5 score significantly (p < 0.001) improved after 28 and 84 days, as did patient satisfaction. Ocular surface staining, Schirmer test, TBUT, and conjunctival hyperemia scores improved significantly (all p < 0.001) for both eyes with SH-trehalose between baseline and day 84. Tolerance of SH-trehalose was good.

conclusionsSH-trehalose significantly improved the clinical signs and symptoms of DED after 84 days. Moreover, it significantly increased patient satisfaction and was well tolerated.

trial registrationNCT04803240.

Indexed as

Dry eye diseaseDry Eye Questionnaire-5 itemsOcular Surface Disease IndexPreservative-free artificial eye dropsPreservativesQuality of lifeSatisfaction

Identifiers

PMID39432158
PMCPMC11564544

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.