Clinical Trials Register

Summary
EudraCT Number:	2016-002172-27
Sponsor's Protocol Code Number:	NGF0116
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-05-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-002172-27

A.3

Full title of the trial

A 8 weeks, Phase II, single-centre, randomized, double-masked, vehicle-controlled, parallel group study with 4 weeks of follow-up to evaluate preliminary efficacy and safety of recombinant human Nerve Growth Factor (rhNGF) eye drops solution versus vehicle in patients after cataract and refractive surgery.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Studio clinico di 8 settimane, di fase II, monocentrico, randomizzato, in doppio cieco, controllato con veicolo, a gruppi paralleli con 4 settimane di follow-up volto a valutare preliminarmente l’efficacia e la sicurezza della soluzione in collirio contenente il fattore di crescita nervoso ricombinante umano (rhNGF) in confronto a veicolo in pazienti che siano stati sottoposti a chirurgia della cataratta o chirurgia refrattiva.

A.3.2

Name or abbreviated title of the trial where available

NGF0116

A.4.1

Sponsor's protocol code number

NGF0116

A.5.4

Other Identifiers

Name:

Number:

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	DOMPé FARMACEUTICI S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	dompé farmaceutici spa
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	DOMPE' FARMACEUTICI SPA
B.5.2	Functional name of contact point	CLINICAL DEVELOPMENT
B.5.3	Address:
B.5.3.1	Street Address	VIA SANTA LUCIA
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390258383322
B.5.5	Fax number	0258383324
B.5.6	E-mail	paolo.battigello@dompe.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	rhNGF
D.3.2	Product code	rhNGF
D.3.4	Pharmaceutical form	Eye drops, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NERVE GROWTH FACTOR (NGF), RICOMBINANTE UMANO
D.3.9.1	CAS number	1772578-74-1
D.3.9.2	Current sponsor code	rhNGF
D.3.9.3	Other descriptive name	NERVE GROWTH FACTOR (NGF), RICOMBINANTE UMANO
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Eye drops, solution
D.8.4	Route of administration of the placebo	Ocular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients after cataract and refractive surgery

pazienti che siano stati sottoposti a chirurgia della cataratta o chirurgia refrattiva

E.1.1.1

Medical condition in easily understood language

patients after cataract and refractive surgery

pazienti che siano stati sottoposti a chirurgia della cataratta o chirurgia refrattiva

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10015919
E.1.2	Term	Eye disorders
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to assess efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery.

Obiettivo primario dello studio è valutare l’efficacia e la sicurezza di soluzione in collirio di rhNGF in pazienti che siano stati sottoposti a chirurgia della cataratta o chirurgia refrattiva.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female ≥18 years old
2. Patients who are characterized by the following clinical features:
a. History of cataract or refractive corneal surgery in the study eye in the previous 6 months;
b. Mean Symptom Assessment in Dry Eye (SANDE) score for severity and frequency of at least 30 at baseline
3. The same eye (study eye) must fulfill all the above criteria
4. Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units in both eyes at the time of study enrolment
5. Female patients must have negative pregnancy urine test if at childbirth potential.
6. Only patients who satisfy all requirements for informed consent may be included in the study. Written Informed Consent must be obtained before the initiation of any study-specific procedures.
7. Patients must have the ability and willingness to comply with study procedures.

Femmine o maschi ≥ 18 anni
2. Pazienti con le seguenti caratteristiche:
 a. Storia di chirurgia corneale della cataratta o refrattiva dell’occhio in studio nei precedenti 6 mesi;
b. Media del punteggio al questionario SANDE (Symptom Assessment iN Dry Eye) per gravità e frequenza di almeno 30 al baseline.
3. Lo stesso occhio (occhio eleggibile) deve soddisfare tutti i criteri di cui sopra.
4. Score BCDVA (Best Corrected Distance Visual Acuity) ≥0.1 unità decimali in entrambi gli occhi al momento dell’arruolamento
5. Donne potenzialmente fertili devono avere test di gravidanza su urine negativo.
6. Solo i pazienti che soddisfano tutti i requisiti per il consenso informato potranno essere inclusi nello studio
7. I pazienti devono avere la capacità e la buona volontà di completare le procedure di studio. Il Consenso informato scritto dovrà essere ottenuto prima di iniziare qualsiasi procedura di studio.

E.4

Principal exclusion criteria

1. Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye at the time of study enrolment.
2. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye.
3. Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results.
4. Use of therapeutic or Refractive Contact lenses in either eye at the time of study enrolment;
5. History of ocular surgery in the study eye, excluding corneal refractive or cataract procedures, within 90 days of study enrolment.
6. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
a. are currently pregnant or,
b. have a positive result at the urine pregnancy test (Baseline/Day 0) or,
c. intend to become pregnant during the study treatment period or,
d. are breast-feeding or,
e. are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or IUD - during the entire course of and 30 days after the study treatment periods.
7. Participation in another clinical study at the same time as the present and within 30 days of study enrolment;
8. History of drug, medication or alcohol abuse or addiction.

1. Qualsiasi malattia oculare diversa da occhio secco che richiede un trattamento con farmaci topic, nell’uno o nell’altro occhio;
2. Qualsiasi infezione oculare attiva o infiammazione attiva nell’uno o nell’altro gli occhi non connessa ad occhio secco;
3. Presenza o storia di qualsiasi disordine sistemico o oculare, condizione o malattia che potrebbero possibilmente interferire con la conduzione delle procedure richieste per lo studio o con l’interpretazione dei risultati di studio
4. Uso di lenti a contatto terapeutiche o refrattive nell’uno o nell’altro occhio, al momento dell’arruolamento;
5. Storia di chirurgia oculare nell’occhio in studio, escluso le procedure di chirurgia refrattiva o della cataratta, nei 90 giorni precedenti l’arruolamento in studio;
6. Donne potenzialmente fertili (che non sono chirurgicamente sterili o in post-menopausa da almeno un anno) sono escluse dalla partecipazione nello studio se incontrano almeno una delle seguenti condizioni:
a) Sono attualmente in gravidanza o,
b) Hanno un risultato positivo al test delle urine (Baseline/giorno 0) o,
c) Intendono intraprendere una gravidanza durante il periodo di trattamento dello studio o,
d) Non hanno la volontà di usare misure di controllo della nascita altamente efficaci, come: contraccettivi ormonali -orali, impiantabili, transdermici, o iniettabili- e/o metodi di barriera meccanici -come spermicidi in associazione con una barriera come preservativo o diaframma o IUD- durante l’intera durata e dopo 30 giorni dalla fine del periodo di trattamento dello studio.
7. Partecipazione ad altri studi clinici allo stesso tempo del presente studio nei 30 giorni dall’arruolamento.
8. Storia di abuso o dipendenza da droga, alcool o farmaci.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of treatment

Obiettivo primario dello studio è valutare l’efficacia e la sicurezza di soluzione in collirio di rhNGF in pazienti che siano stati sottoposti a chirurgia della cataratta o chirurgia refrattiva.

E.5.1.1

Timepoint(s) of evaluation of this end point

This endpoint will be evaluated at each time point (days 0, 28±2, 56±2 and 28±2 days after discontinuation of treatment

Questo endpoint sarà valutato ad ogni visita (giorno 0, giorno 28±2, giorno 56±2, giorno 28±2 dopo la fine del trattamento

E.5.2

Secondary end point(s)

Changes in SANDE scores (face values) for severity and frequency

Cambiamenti nello score SANDE per frequenza e gravità

E.5.2.1

Timepoint(s) of evaluation of this end point

(days 0, 28±2, 56±2 and 28±2 days after discontinuation of treatment)

(giorno 0, giorno 28±2, giorno 56±2, giorno 28±2 dopo la fine del trattamento)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

LVLs

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

Information not present in EudraCT

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

According to clinical practice

In accordo alla pratica clinica

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-11-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-09-04

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