Evidence map›Paper›PMID 30944103›Full record

Trial reportThe British journal of ophthalmology2020

Effect of recombinant human nerve growth factor eye drops in patients with dry eye: a phase IIa, open label, multiple-dose study.

Marta Sacchetti, Alessandro Lambiase, Doreen Schmidl, Leopold Schmetterer, Mauro Ferrari, Flavio Mantelli, Marcello Allegretti, Gerhard Garhoefer

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The British journal of ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02101281 (An Open-label Study Evaluating Safety and Efficacy of Recombinant Human Nerve Growth Factor), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
–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.

NCT02101281 phase2completednot on this map

An Open-label Study Evaluating Safety and Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drops at Different Doses in Patients With Dry Eye

TypeinterventionalSponsorDompé Farmaceutici S.p.ARan2014 to 2015Enrolled40ConditionsDry Eye SyndromeArmsrhNGF 20 µg/mL, rhNGF 4 µg/mL
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Toward an NGF-based therapy for Rett syndrome.Frontiers in neuroscience · 2026
    Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Non-contact confocal calcium imaging ofBiomedical optics express · 2025
    Article
  11. Evaluation ofFrontiers in bioengineering and biotechnology · 2025
    Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. 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

8 authors.

Marta SacchettiDepartment of Sense Organs, University Sapienza of Rome, Rome, Italy.
Alessandro LambiaseDepartment of Sense Organs, University Sapienza of Rome, Rome, Italy alessandro.lambiase@uniroma1.it.ORCID 0000-0002-8974-991X
Doreen SchmidlDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Leopold SchmettererDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-7189-1707
Mauro FerrariDompe farmaceutici SpA, Milano, Italy.
Flavio MantelliDompe farmaceutici SpA, Milano, Italy.
Marcello AllegrettiDompe farmaceutici SpA, Milano, Italy.
Gerhard GarhoeferDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDry eye disease (DED) affects more than 14% of the elderly population causing decrease of quality of life, high costs and vision impairment. Current treatments for DED aim at lubricating and controlling inflammation of the ocular surface. Development of novel therapies targeting different pathogenic mechanisms is sought-after. The aim of this study is to evaluate safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops in patients with DED.

methodsForty consecutive patients with moderate to severe DED were included in a phase IIa, prospective, open label, multiple-dose, clinical trial to receive rhNGF eye drops at 20 µg/mL (Group 1: G1) or at 4 µg/mL (Group 2: G2) concentrations, two times a day in both eyes for 28 days (NCT02101281). The primary outcomes measures were treatment-emerged adverse events (AE), Symptoms Assessment in Dry Eye (SANDE) scale, ocular surface staining and Schirmer test.

resultsOf 40 included patients, 39 completed the trial. Both tested rhNGF eye drop concentrations were safe and well tolerated. Twenty-nine patients experienced at least one AE (14 in G1 and 15 in G2), of which 11 had at least 1 related AE (8 in G1 and 3 in G2). Both frequency and severity of DED symptoms and ocular surface damage showed significant improvement in both groups, while tear function improved only in G1.

conclusionsThe data of this study indicate that rhNGF eye drops in both doses is safe and effective in improving symptoms and signs of DED. Randomised clinical trials are ongoing to confirm the therapeutic benefit of rhNGF in DED. TRIAL REGISTRATION NUMBER: NCT02101281.

Indexed as

AdultAgedDose-Response Relationship, DrugDrug Administration ScheduleDry Eye SyndromesFemaleHumansLubricant Eye DropsMaleMiddle AgedNerve Growth FactorsRecombinant ProteinsSeverity of Illness IndexTearsTreatment OutcomeLubricant Eye DropsNerve Growth FactorsRecombinant Proteinsclinical trialocular surfacepharmacologytears

Identifiers

PMID30944103
PMCPMC6922013

What OpenQuestion holds

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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.