Evidence map›Paper›PMID 39379885›Full record

Trial reportBMC ophthalmology2024

Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial.

Eric Donnenfeld, Jade Coats, Krista Barbour, Robert Ryan, Nabin R Joshi, Laura M Periman

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03995355 (Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03995355 completednot on this map

Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients

TypeinterventionalSponsorJohnson & Johnson Vision Care, Inc.Ran2019 to 2019Enrolled161ConditionsVisual AcuityArms9618X investigational lipid eye drops, Blink® Tears
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

6 authors.

Eric DonnenfeldOphthalmic Consultants of Long Island, Fairfield, CT, USA.
Jade CoatsMcDonald Eye Associates, Fayetteville, AR, USA.
Krista BarbourBausch + Lomb, Inc., Rochester, NY, USA.
Robert RyanBausch + Lomb, Inc., Rochester, NY, USA.
Nabin R Joshi, Johnson & Johnson, New Brunswick, NJ, USA.
Laura M PerimanPeriman Eye Institute, Seattle, WA, USA. dryeyemaster@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDry eye disease (DED) is a prevalent condition affecting over 16 million patients in the USA. DED and the symptoms of ocular discomfort are debilitating and a significant burden on patients. If left untreated, DED can progress to cause severe pathology. Treatment is often initiated by patients without consulting a healthcare professional. This study investigated the safety and efficacy of a novel lipid-containing eye drop (BTC), which might better mimic the components of natural tears.

methodsThis was a multicenter, randomized, double-masked, active control, two arm, parallel group study of eye drops in adult subjects with self-reported DED. Subjects were randomly assigned to BTC or control (commercially available non-lipid eye drops; NLED) arm and were followed for 30 days. Assessments using visual analog scale and patient-reported outcomes (PRO) questionnaires, non-invasive tear break up time, slit-lamp examination, and subject-reported ocular symptoms were conducted at baseline and at days 7 and 30. The primary endpoint was change in overall ocular comfort score from baseline to day 30.

results158 subjects were randomized, of whom 130 completed the study per protocol (PP). Mean (SD) age was 47.8 (14.14) years. The mean (95% CI) change in overall comfort scores at the 30-day follow-up in the PP population was 21.4 (15.1, 27.7) for the test drop and 10.0 (3.9, 16.1) for the comparator. The mean (95% CI) treatment difference was 11.3 (2.6, 20.1); this met the pre-defined requirements for non-inferiority. There was no significant difference in the proportion of eyes with reported ocular symptoms between the groups. At day 7, the OR (95% CI) was 0.967 (0.528, 1.770) and at day 30 was 1.160 (0.610, 2.203). There were no Grade 3 or higher corneal edema, corneal neovascularization, corneal staining, conjunctival injection, tarsal abnormalities or any other biomicroscopy findings, and no corneal infiltrates observed during the study.

conclusionsThe investigational lipid eye drop BTC was noninferior to the commercially available non-lipid comparator in all parameters measured and has the potential to provide an effective therapy for subjects with symptoms of dry eye who would benefit from a lipid-based artificial tear.

trial registrationNCT03995355 ( http://www. CLINICALTRIALS: gov ), registered June 24, 2019.

Indexed as

Dry Eye SyndromesLipidsLubricant Eye DropsTearsAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedOphthalmic SolutionsSurveys and QuestionnairesTreatment OutcomeLipidsLubricant Eye DropsOphthalmic SolutionsArtificial tearDry eyeLipid eye dropOcular surface disease

Identifiers

PMID39379885
PMCPMC11459852

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.