Evidence map›Paper›PMID 33116367›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2020

Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial.

Steven Silverstein, Elizabeth Yeu, Joseph Tauber, Michel Guillon, Lyndon Jones, David Galarreta, Sruthi Srinivasan, Venkiteshwar Manoj

Open access · goldAbstract read
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 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

13 citing papers in PubMed, 22 citations in OpenAlex.

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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 6 institutions in 3 countries.

Steven SilversteinSilverstein Eye Centers, Kansas City, MO 64133, USA.ORCID 0000-0002-8243-2485
Elizabeth YeuVirginia Eye Consultants, Norfolk, VA 23502, USA.ORCID 0000-0002-3453-3062
Joseph TauberTauber Eye Center, Kansas City, MO 64155, USA.ORCID 0000-0001-5365-8795
Michel GuillonOcular Technology Group International, London SW1E 6AU, UK.ORCID 0000-0002-1929-8690
Lyndon JonesCentre for Ocular Research & Education (CORE), School of Optometry and Vision Science, Waterloo, ON NL2 3G1, Canada.ORCID 0000-0002-7409-7349
David GalarretaHospital Clinico Universitario de Valladolid, Valladolid Castilla y Leon 47011, Spain.ORCID 0000-0001-5649-6971
Sruthi SrinivasanAlcon Research, LLC, Johns Creek, GA, USA.ORCID 0000-0001-9697-1343
Venkiteshwar ManojAlcon Research, LLC, Johns Creek, GA, USA.
Alcon (United States) · USHospital Clínico Universitario de Valladolid · ESStar Center · USTauber Eye Center · USUniversity of Waterloo · CAVirginia Eye Consultants · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate symptom relief in patients with dry eye disease (DED) following a single drop of propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane

methodsThis was a Phase IV, multicenter, open-label, interventional study in adult patients with DED of aqueous-deficient, evaporative, and mixed subtypes. Patients instilled one drop of PG-HPG in each eye at Day 1. Endpoints included change from baseline in dry eye symptom and soothing sensation scores on Day 1 at 0, 4, and 8 hours post-dose. Symptom scores were assessed on a 0-10 scale (0=no symptoms; 10=worst imaginable symptom). Tolerability of the drop was assessed based on assessment score on Day 1 following instillation for overall cohort and by DED subtype.

resultsA total of 134 patients received treatment (mean age: 56.6 years; female: 75.4%). Median changes from baseline at Day 1 in dry eye symptom scores were -1.0 (95% confidence interval [CI]:-3.0,-1.0), -2.0 (95% CI:-3.0,-2.0), and -2.0 (95% CI:-2.0,-1.0) at 0, 4, and 8 hours respectively. Subgroup analysis showed a median change from baseline in dry eye symptom score of -2 (95% CI:-3.0,-1.0) for aqueous-deficient and evaporative subtypes and -1 (95% CI:-3.0,-1.0) for mixed subtype at 8 hours. Median soothing sensation scores were 3 at 0 and 4 hours and 3.5 at 8 hours, with a range of 0-10. Median (range) tolerability assessment scores were 0 (0-8) for burning sensation, stinging sensation, blurring, and 0 (0-10) for foreign body sensation. Tolerability assessment scores by DED subtype confirmed that the majority of patients reported scores in the range of 0-5 for all components and in all subgroups analyzed.

conclusionOur study demonstrated that PG-HPG nanoemulsion provided instant/immediate and sustained symptom relief for 8 hours post-single application and was well tolerated in patients with DED, demonstrated by their responses on each of the assessment scales.

Indexed as

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

Identifiers

PMID33116367
PMCPMC7555274
OpenAlexW3092150685

What OpenQuestion holds

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Registered trials

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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.