Evidence map›Paper›PMID 39485593›Full record

ArticleOphthalmology and therapy2024

Phospholipid Nanoemulsion-Based Ocular Lubricant for the Treatment of Dry Eye Subtypes: A Multicenter and Prospective Study.

Maria Cristina Nishiwaki-Dantas, Denise de Freitas, Denise Fornazari, Myrna Serapião Dos Santos, Tais Hitomi Wakamatsu, Caroline Nascimento Barquilha, Marília Trindade Ferrer, Helga Caputo Nunes Holzhausen, Monica Alves

Abstract 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. 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.

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. Review
  2. Translating Biomarker Discovery: From Bench to Bedside in Dry Eye Disease.International journal of molecular sciences · 2025
    Review
  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

9 authors.

Maria Cristina Nishiwaki-DantasDepartment of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.
Denise de FreitasDepartment of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.
Denise FornazariDepartment of Ophthalmology and Otorhinolaryngology, University of Campinas, Campinas, SP, Brazil.
Myrna Serapião Dos SantosDepartment of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.
Tais Hitomi WakamatsuDepartment of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.
Caroline Nascimento BarquilhaBrazilian Biosciences National Laboratory, Campinas, SP, Brazil.
Marília Trindade FerrerDepartment of Ophthalmology and Otorhinolaryngology, University of Campinas, Campinas, SP, Brazil.
Helga Caputo Nunes HolzhausenBrazilian Biosciences National Laboratory, Campinas, SP, Brazil.
Monica AlvesDepartment of Ophthalmology and Otorhinolaryngology, University of Campinas, Campinas, SP, Brazil. monicalves@me.com.ORCID http://orcid.org/0000-0001-7940-0194

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 (OS) characterized by loss of tear film homeostasis, ocular discomfort, and vision disturbances. Most available ocular lubricants target the aqueous deficiency of the tear, restoring only this layer, leaving the tear lipid stratum deficient, as occurs in most patients with evaporative DED. An innovative propylene glycol-hydroxypropyl guar enriched with a phospholipid nanoemulsion (PG-HPG-PH-N) is indicated to restore deficiencies in both the lipid and aqueous layers of the tear film, and its composition was designed to increase lubricant retention on the OS. The purpose of this study was to evaluate, through the Ocular Surface Disease Index (OSDI) and clinical assessment, the treatment of patients who had DED due to aqueous deficiency arising from mixed or evaporative DED subtypes with a PG-HPG-PH-N ocular lubricant at a reduced frequency of twice a day, in a prospective, multicenter, and single-arm study.

methodsPatients were screened from days - 7 to 0, and from day 1 (baseline and first day of treatment) to day 28 of treatment with this lubricant. After visit 1 (screening visit, days - 7 to 0), designed as pre-treatment OS assessment, patients returned to their research center on days 14 and 28 of treatment for a complete assessment, including anamnesis, the OSDI, corrected visual acuity, tear breakup time (TFBUT), OS staining evaluation, tolerability index, and environmental exposure questionnaire.

resultsSeventy patients were enrolled in this study (60 women, 10 men), with a mean age of 45 (range 27-64) years. TFBUT results showed an improvement in tear film stability as vital dyes sodium fluorescein and lysamine green showed a decrease in corneal staining after 14 and 28 days of treatment. No significant adverse events were reported, demonstrating the good tolerability of the lubricant.

conclusionsThe PG-HPG-PH-N nanoemulsion can be considered to be a safe and effective ocular lubricant for treating DED due to aqueous deficiency, both mixed and evaporative subtypes.

trial registrationBrazilian National Research Ethics Commission (ReBEC registration number 16055).

Indexed as

Dry eye diseaseDry eye subtypesLubricantPhospholipid nanoemulsion

Identifiers

PMID39485593
PMCPMC11564604

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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.