Evidence map›Paper›PMID 32943837›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2020

Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial.

Elizabeth Yeu, Steven Silverstein, Michel Guillon, Marc-Matthias Schulze, David Galarreta, Sruthi Srinivasan, Venkiteshwar Manoj

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.2field-weighted citation impact, top 11% 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.

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

19 citing papers in PubMed, 31 citations in OpenAlex.

  1. Effects of HP-Guar Nano-emulsion Artificial Tears on Symptoms and Severity of Meibomian Gland Dysfunction in Evaporative Dry Eye During a 90-Day Longitudinal Study.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026
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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

7 authors at 5 institutions in 3 countries.

Elizabeth YeuVirginia Eye Consultants, Norfolk, VA 23502, USA.
Steven SilversteinSilverstein Eye Centers, Kansas City, MO 64133, USA.ORCID 0000-0002-8243-2485
Michel GuillonOcular Technology Group International, London SW1E 6AU, UK.ORCID 0000-0002-1929-8690
Marc-Matthias SchulzeCentre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario NL2 3G1, Canada.ORCID 0000-0002-4025-553X
David GalarretaHospital Clinico Universitario de Valladolid, Valladolid Castillay Leon 47011, Spain.ORCID 0000-0001-5649-6971
Sruthi SrinivasanAlcon Research, LLC, Johns Creek, GA 30097, USA.
Venkiteshwar ManojAlcon Research, LLC, Johns Creek, GA 30097, USA.
Alcon (United States) · USHospital Clínico Universitario de Valladolid · ESStar Center · USUniversity of Waterloo · CAVirginia Eye Consultants · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the clinical efficacy and safety of propylene glycol/hydroxypropyl-guar (PG-HPG)-based nanoemulsion (Systane PARTICIPANTS AND

methodsIn this phase IV, open-label, single-arm, interventional, multicenter study, adult participants with DED - subtyped into aqueous deficient, evaporative, and mixed dry eye - were instructed to instill one drop of PG-HPG in each eye twice a day for 28 days. Endpoints included change from baseline in tear film break-up time (TFBUT) (primary) and ocular discomfort visual analog scale (VAS) score at Day 14 and TFBUT at Day 28 (secondary). Safety was assessed throughout the study. Data were analyzed for overall patient cohort and by DED subtypes.

resultsA total of 134 participants received treatment (mean age: 56.6 years; female: 75.4%). At Day 14, the mean (standard deviation [SD]) TFBUT increased from 2.6 (1.00) seconds at baseline to 4.2 (2.92) seconds (mean change: 1.5 [2.80] seconds); median change was 0.8 seconds (95% CI: 0.52, 1.19) for the overall cohort; the change was maintained at Day 28 (mean change: 1.4 (2.80) seconds, median change: 0.8 seconds (95% CI: 0.49, 1.17). Subgroup analysis showed a mean change (SD) from baseline in TFBUT of 1.1 (2.41) seconds for aqueous deficient, 2.4 (3.17) seconds for evaporative, and 1.2 (2.63) seconds for mixed dry eye at Day 14, respectively. The ocular discomfort VAS score improved (decreased) from baseline at Day 14 (mean [SD] change: -17.3 [24.80]) for the overall cohort, -22.0 [21.73] for aqueous deficient, -17.6 [24.17] for evaporative and -13.1 [27.49] for mixed dry eye subgroups). Adverse events (AEs) were reported in 9 (6.7%) participants. No serious AEs were reported during the study.

conclusionOur study findings demonstrated that PG-HPG-based nanoemulsion lubricant eye drops were effective and well tolerated in participants with DED and all of its subtypes.

Indexed as

aqueous deficient dry eyedry eye diseaseevaporative dry eyemixed dry eyepropylene glycol/hydroxypropyl guar-nanoemulsion ocular lubricant

Identifiers

PMID32943837
PMCPMC7478376
OpenAlexW3081761642

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.