Clinical Trials Register

Summary
EudraCT Number:	2010-024272-26
Sponsor's Protocol Code Number:	GLC-05-10
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:	2012-03-20
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

2010-024272-26

A.3

Full title of the trial

Comparison of the effects of Bimatoprost 0.01% and Timolol 0.5% on circadian intraocular pressure

Confronto tra gli effetti del Bimatoprost 0.01% e Timololo 0.5% sulla pressione intraoculare circadiana

A.3.1

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

Comparison between the effects on ocular pressure of Bimatoprost 0.01% and Timolol 0.5% during the day and night

Confronto tra gli effetti sulla pressione degli occhi del Bimatoprost 0.01% e Timololo 0.5% di giorno e di notte

A.4.1

Sponsor's protocol code number

GLC-05-10

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	IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS
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
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	IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA
B.5.2	Functional name of contact point	unita' di ricerca glaucoma
B.5.3	Address:
B.5.3.1	Street Address	VIA LIVENZA 3
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00198
B.5.3.4	Country	Italy
B.5.4	Telephone number	0685356727
B.5.5	Fax number	0684242333
B.5.6	E-mail	lucia.tanga@gmail.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	Yes
D.2.1.1.1	Trade name	LUMIGAN*COLL FL 3ML 0,1MG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ALLERGAN SpA
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.3.4	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	BIMATOPROST
D.3.9.1	CAS number	155206-00-1
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	.1
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	TIMOLOLO NOVARTIS*OFT 5ML 0,5%
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS FARMA SpA
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.3.4	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	TIMOLOL MALEATE
D.3.9.1	CAS number	26921-17-5
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

glaucoma and ocular hypertension

glaucoma ed ipertensione oculare

E.1.1.1

Medical condition in easily understood language

ocular hypertension and optic nerve degeneration due to ocular pressure

pressione alta degli occhi e degenerazione del nervo ottico dovuta alla pressione intraoculare

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10030348
E.1.2	Term	Open angle glaucoma
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

to investigate the 24-hour IOP lowering efficacy and safety of Bimatoprost 0.01% administered once at night compared to Timolol 0.5% administered twice daily

valutare l’efficacia del Lumigan 0.01% rispetto al Timololo 0.5% nel ridurre la IOP durante le 24 ore.

E.2.2

Secondary objectives of the trial

evaluete: mean 24-hours IOP changes from baseline, IOP at each time point of the daily curve, mean day and night IOP, ocular hyperemia score, mean 24-hours systolic and diastolic blood pressure, mean 24-hours heart rate, incidence of adverse events, responses from questionnaire about drug tolerability and satisfaction

valutare: • I cambiamenti della IOP media durante le 24 ore rispetto alla visita basale. • La IOP media di ogni misurazione durante la curva giornaliera. • I cambiamenti della IOP media di ogni misurazione della curva giornaliera. • La media della IOP giornaliera (8:00, 12:00, 16:00, 20:00) e media della IOP notturna (0:00, 4:00). • La media della pressione arteriosa diastolica e sistolica e della frequenza cardiaca durante le 24 ore. • La presenza di eventi avversi. • Le risposte del questionario riguardo alla tollerabilità del farmaco

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Signed informed consent • Age> 18 years • Diagnosis of glauocoma or ocular hypertension. The definition of glaucoma or ocular hypertension is based on the guidelines of the 'European Glaucoma Society • Patients newly diagnosed (Ocular hypertension and glaucoma) and never treated with ocular hypotensive drugs with any value tonometer and patients with OHT and POAG in ocular hypotensive drug therapy alone and with IOP <22mmHg at the screening visit.

• Firma del consenso informato • Età >18 anni • Diagnosi di glaucoma o ipetensione oculare. La definizione di glaucoma e di ipertensione oculare è basata sulle linee guida dell’ “European Glaucoma Society” • Pazienti di nuova diagnosi e mai trattati con farmaci ipotensivi oculari con qualsiasi valore tonometrico e pazienti con glaucoma o ipertensione oculare in terapia con farmaci ipotensivi oculari in monoterapia e con IOP< 22mmHg alla visita di screening.

E.4

Principal exclusion criteria

Inability to sign informed consent • Ocular conditions that can interfere with the results of the study • Narrow angle or a history of acute attacks of glaucoma • eye infection or inflammation in the 3 months preceding the screening visit • eye surgery, or argon laser trabeculoplasty in the last three months. • History of hypersensitivity to benzalkonium chloride or other components contained in the formulation of study drug • Use of topical drugs that may interfere with the study medication • Causes of secondary increase of intraocular pressure • Contraindications to the use of systemic drugs in the studio

• Inabilità a firmare il Consenso informato • Condizioni oculari che posso interferire con i risultati dello studio • Angolo stretto o storia di attacchi acuti di glaucoma • Infezioni o infiammazioni oculari nei 3 mesi precedenti alla visita di screening • Chirurgia oculare, trabeculoplastica o argon laser negli ultimi tre mesi. • Storia di Ipersensibilità al benzalconio cloruro o ad altri componenti contenuti nella formulazione del farmaco in studio • Uso di farmaci topici che possano interferire con il farmaco in studio • Cause di aumento secondario delle pressione intraoculare • Controindicazioni sistemiche all’utilizzo dei farmaci in studio

E.5 End points

E.5.1

Primary end point(s)

comparison between groups of the 24-hour mean IOP after 8 weeks of treatment

confrontare la pressione intraoculare media dopo 8 settimane di trattamento con Lumigan 0.01% e Timololo 0.5% Novartis

E.5.1.1

Timepoint(s) of evaluation of this end point

5 months

5 mesi

E.5.2

Secondary end point(s)

mean 24-hours IOP changes from baseline, IOP at each time point of the daily curve, mean day and night IOP, ocular hyperemia score, mean 24-hours systolic and diastolic blood pressure, mean 24-hours heart rate, incidence of adverse events, responses from questionnaire about drug tolerability and satisfaction

Valutare dopo 8 settimane di trattamento: • I cambiamenti della IOP media durante le 24 ore rispetto alla visita basale. • La IOP media di ogni misurazione durante la curva giornaliera. • I cambiamenti della IOP media di ogni misurazione della curva giornaliera. • La media della IOP giornaliera (8:00, 12:00, 16:00, 20:00) e media della IOP notturna (0:00, 4:00). • La media della pressione arteriosa diastolica e sistolica e della frequenza cardiaca durante le 24 ore. • La presenza di eventi avversi. • Le risposte del questionario riguardo alla tollerabilità del farmaco

E.5.2.1

Timepoint(s) of evaluation of this end point

5 months

5 mesi

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

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Yes

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

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

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

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.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)

Patients will continue to be treated and controlled as in commnon clinical practice

i pazienti continueranno ad essere curati e seguiti nella comune 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

2011-04-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-14

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

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