Evidence map›Paper›PMID 28452989›Full record

Trial reportEye (London, England)2017

Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye.

M Labetoulle, F Chiambaretta, A Shirlaw, R Leaback, C Baudouin

Erratum issued Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2017. 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 NCT02117687 (A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.7field-weighted citation impact, top 10% 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.

NCT02117687 phase4completednot on this map

A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye

TypeinterventionalSponsorAllerganRan2014 to 2015Enrolled80ConditionsDry Eye Syndromes, Keratoconjunctivitis SiccaArmscarboxymethylcellulose 0.5%/glycerin 0.9%, sodium hyaluronate 0.18%
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Performance and Safety of a Sodium Hyaluronate Tear Substitute with Polyethylene Glycol in Dry Eye Disease: A Multicenter, Investigator-Masked, Randomized, Noninferiority Trial.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2022
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  16. Review
  17. Physicochemical Properties of Hyaluronic Acid-Based Lubricant Eye Drops.Translational vision science & technology · 2019
    Article
  18. Effect of Refresh PlusClinical ophthalmology (Auckland, N.Z.) · 2019
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

M LabetoulleService d'Ophtalmologie, CHU Bicêtre, APHP, Université Paris Sud, Paris, France.
F ChiambarettaService d'Ophtalmologie, CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
A ShirlawAllergan plc, Marlow, UK.
R LeabackAllergan plc, Marlow, UK.
C BaudouinCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Université de Versailles Saint-Quentin-en-Yvelines, Paris, France.
Allergan (United Kingdom) · GBCentre hospitalier national d'ophtalmologie des Quinze-Vingts · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FRUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PurposeTo assess the safety and efficacy of an eye drop combining osmoprotectants, carboxymethylcellulose and hyaluronic acid (O/CMC/HA) in reducing symptomatic, moderate to severe dry eye, compared with HA.MethodsIn this investigator-masked, randomised study, patients instilled 1-2 drops/eye of O/CMC/HA or HA (2-6 times/day) for 3 months. Primary endpoint: mean change in Global Ocular Staining Score (GOSS) from baseline at day 35. Noninferiority of O/CMC/HA was tested in the per-protocol population; if achieved, superiority was tested in the intent-to-treat population. Secondary efficacy endpoints: mean change from baseline in GOSS, Ocular Surface Disease Index (OSDI), Schirmer score, tear break-up time (TBUT), corneal/conjunctival staining, conjunctival hyperaemia, symptoms, and patient/investigator assessments.ResultsBaseline characteristics were comparable between groups (n=40 each). O/CMC/HA was noninferior (and not superior) to HA based on similar GOSS reductions from baseline at day 35 and month 3 in both groups (P=0.778, day 35, per-protocol population). Overall, O/CMC/HA and HA provided similar reductions in OSDI, Schirmer score, TBUT, corneal staining and hyperaemia from baseline at 35 days (P≥0.155). More patients reported less severe stinging/burning, sandiness/grittiness, and painful/sore eyes at month 3 with O/CMC/HA (P≤0.039), and more rated the dropper bottle easy to use (87.5%), compared with HA (46.2%; P=0.002). Other patient and investigator assessments were similar between groups. O/CMC/HA and HA were well tolerated.ConclusionsO/CMC/HA is noninferior to HA in improving objective signs of dry eye, with potential advantages for subjective symptoms and patient acceptance.

Indexed as

Carboxymethylcellulose SodiumDose-Response Relationship, DrugDrug Administration ScheduleDry Eye SyndromesFemaleHumansHyaluronic AcidMaleMiddle AgedOphthalmic SolutionsOsmosisSeverity of Illness IndexTearsTreatment OutcomeViscosupplementsCarboxymethylcellulose SodiumHyaluronic AcidOphthalmic SolutionsViscosupplements

Identifiers

PMID28452989
PMCPMC5639191
OpenAlexW2608007546

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.