Clinical Trials Register

Summary
EudraCT Number:	2013-001634-17
Sponsor's Protocol Code Number:	MAF/ISS/OPH/GLA/035
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-07-04
Trial 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

2013-001634-17

A.3

Full title of the trial

LONG-TERM 24-HOUR INTRAOCULAR PRESSURE CONTROL AND PROGRESSION RATE OBTAINED WITH THE ASSOCIATION OF COMBIGAN IN THE MORNING AND GANFORT IN THE EVENING COMPARED WITH LATANOPROST IN HIGH RISK OPEN-ANGLE GLAUCOMA.

Controllo della pressione intraoculare nelle 24 ore e velocità di progressione della malattia ottenuto con la somministrazione di Combigan al mattino e Ganfort la sera rispetto alla somministrazione di Latanoprost la sera nei pazienti con nuova diagnosi di glaucoma ad angolo aperto o Glaucoma esfoliativo ad alto rischio di progressione.

A.3.1

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

A.4.1

Sponsor's protocol code number

MAF/ISS/OPH/GLA/035

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	AZIENDA OSPEDALIERA S. PAOLO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Allergan Pharmaceuticals
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AZIENDA OSPEDALIERA SAN PAOLO
B.5.2	Functional name of contact point	Director of ophthalmology
B.5.3	Address:
B.5.3.1	Street Address	Via A. Di Rudinì, 8
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20142
B.5.3.4	Country	Italy
B.5.4	Telephone number	0250323150
B.5.5	Fax number	0250323150
B.5.6	E-mail	luca.rossetti@unimi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	COMBIGAN COLLIRIO 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ALLERGAN SPA
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
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	COMBIGAN
D.3.4	Pharmaceutical form	Eye drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ophthalmic use (Noncurrent)
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	GANFORT 0,3 mg/ml + 5 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	ALLERGAN SPA
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
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	GANFORT
D.3.4	Pharmaceutical form	Ear drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ophthalmic use (Noncurrent)
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	No
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	LATANOPROST
D.2.1.1.2	Name of the Marketing Authorisation holder	RATIOPHARM ITALIA SRL
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	LATANOPROST
D.3.2	Product code	LATANOPROST
D.3.4	Pharmaceutical form	Eye drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ophthalmic use (Noncurrent)
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with glaucoma open angle or glaucoma exfoliative with high risknewly diagnosed and untreated.

Pazienti con glaucoma angolo aperto o glauco esfoliativo ad alto rischio con nuova diagnosi e non trattati.

E.1.1.1

Medical condition in easily understood language

Patients with glaucoma open angle or glaucoma exfoliative with high risknewly diagnosed and untreated.

Pazienti con glaucoma angolo aperto o glauco esfoliativo ad alto rischio con nuova diagnosi e non trattati.

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare for the first time the quality of 24-hour IOP control obtained after 3 and 24 months of therapy with the combined administration of Combigan in the morning and Ganfort in the evening versus latanoprost administered once in the evening, in high risk newly diagnosed untreated patients with primary open-angle glaucoma (POAG), or exfoliative glaucoma (XFG) with IOP equal to or greater than 27 mm Hg and a visual field defect with an MD of at least -5 dB.

Controllo della pressione Intraoculare nelle 24 ore e velocità di progressione della malattia ottenuto con la somministrazione di Combigan al mattino e Ganfort la sera rispetto alla somministrazione di Latanoprost la sera nei pazienti con nuova diagnosi di Glaucoma ad angolo aperto o Glaucoma esfoliativo ad alto rischio di progressione.

E.2.2

Secondary objectives of the trial

To identify the best long-term 24-hour IOP predictors for progression (e.g. determine the value of peak, mean or fluctuation of IOP over 24 hours). The study will correlate for the first time level of 24-hour IOP and progression rate, thus allowing the determination of a "safe" 24-hour IOP level with which nearly all at-risk XFG and POAG patients will not progress. The study will identify the long-term 24-hr IOP efficacy of the 2 selected therapeutic regimens in a group of at-risk glaucoma patients (high baseline IOP and POAG, or XFG). This study will demonstrate, for the first time, that early, effective 24-hour IOP lowering with fixed combination therapy can save sight years.

identificare i migliori indici per la progressione della malattia (per esempio determinare il valore di picco, media e fluttuazione della IOP nelle 24 ore). Correlare per la prima volta i livelli di IOP nelle 24 ore ed il tasso di progressione, determinando un livello di IOP sicuro entro il quale quasi tutti i pazienti con POAG ed XFG non progrediranno. Lo studio è mirato a verificare (per la prima volta in letteratura) se uno schema di trattamento aggressivo applicato in fase precoce, sia in grado di salvare anni di vista.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Newly diagnosed untreated patients;
-Willingness to comply with the investigator’s and protocol’s instructions;
->21 years of age;
-IOP equal to 27 mm Hg or more, at 10:00 am;
-Early to moderate POAG or XFG, exhibiting a visual field damage between –5 dB and -12 dB;
-High risk profile for progression.

-Nuova diagnosi di glaucoma su pazienti non trattati;
-Disponibilità a rispettare il protocollo;
-Età maggiore di anni 21
;-IOP uguale o maggiore di 27 mmHg alle 10.00 di mattina;
-Iniziale o moderato Glaucoma ad angolo aperto o esfoliativo con un Campo Visivo che abbia valori compresi tra -5 dB e -12 Db;
-Alto rischio di progressione.

E.4

Principal exclusion criteria

- < 21 years of age;
- On any medication that can interfere with study drugs;
- Any comorbidity that could interfere with disease progress or VF reading;
- Ocular surgery within last 6 months;
- Pregnancy;
- Allergic or intolerable to any components in study drugs;
- Participating in any other study;
- Inability to give informed consent;
-Reactive airway disease, second or third degree heart block, poorly compensated congestive heart failure or concomitant use of systemic beta-blockers.

- Età minore di 21 anni;
- Qualsiasi medicazione che possa interferire con I farmaci dello studio;
- Qualsiasi comorbidità che possa interferire con la progression della malattia o la lettura del Campo Visivo;
- Chirurgia oculare entro gli ultimi 6 mesi
- Gravidanza;
- Allergia o intollerabilità ad un componente del farmaco in studio;
- Partecipazione in altri studi;
- Inabilità ad accettare il consesnso informato;
- Malattia reattiva delle vie aeree, blocco cardiaco di secondo o terzo grado, insufficienza cardiaca mal compensata o uso concomitatnte di beta bloccanti sistemici.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

2 YEARS

2 ANNI

E.5.2

Secondary end point(s)

Identificare i migliori indici per la progressione della malattia (per esempio determinare il valore di picco, media e fluttuazione della IOP nelle 24 ore).
Correlare per la prima volta i livelli di IOP nelle 24 ore ed il tasso di progressione, determinando un livello di IOP sicuro entro il quale quasi tutti i pazienti con POAG ed XFG non progrediranno.
Lo studio è mirato a verificare (per la prima volta in letteratura) se uno schema di trattamento aggressivo applicato in fase precoce, sia in grado di salvare anni di vista.

E.5.2.1

Timepoint(s) of evaluation of this end point

2 YEARS

2 ANNI

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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

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.8.5

The trial involves multiple Member States

Yes

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

E.8.7

Trial has a data monitoring committee

Yes

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

DH GLAUCOMA

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

2013-10-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-17

P. End of Trial
P.	End of Trial Status	Ongoing

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