Effect of recombinant human nerve growth factor eye drops in patients with dry eye: a phase IIa, open label, multiple-dose study.
Adult
Aged
Dose-Response Relationship, Drug
Drug Administration Schedule
Dry Eye Syndromes
/ drug therapy
Female
Humans
Lubricant Eye Drops
/ administration & dosage
Male
Middle Aged
Nerve Growth Factors
/ administration & dosage
Recombinant Proteins
/ administration & dosage
Severity of Illness Index
Tears
/ physiology
Treatment Outcome
clinical trial
ocular surface
pharmacology
tears
Journal
The British journal of ophthalmology
ISSN: 1468-2079
Titre abrégé: Br J Ophthalmol
Pays: England
ID NLM: 0421041
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
24
04
2018
revised:
19
02
2019
accepted:
09
03
2019
pubmed:
5
4
2019
medline:
29
7
2020
entrez:
5
4
2019
Statut:
ppublish
Résumé
Dry 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. Forty 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. Of 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. The 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. NCT02101281.
Sections du résumé
BACKGROUND
Dry 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.
METHODS
Forty 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.
RESULTS
Of 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.
CONCLUSIONS
The 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.
Identifiants
pubmed: 30944103
pii: bjophthalmol-2018-312470
doi: 10.1136/bjophthalmol-2018-312470
pmc: PMC6922013
doi:
Substances chimiques
Lubricant Eye Drops
0
Nerve Growth Factors
0
Recombinant Proteins
0
Banques de données
ClinicalTrials.gov
['NCT02101281']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
127-135Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: MS and AL: Consultant—Dompé Farmaceutici SpA. MA, FM and MF: Employee—Dompé Farmaceutici SpA. MS, AL: report personal fees from Dompé Farmaceutici SpA, Italy, outside the submitted work. MA, MS, MF, GG: report personal fees from Dompe Farmaceutici spa, during the conduct of the study.
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