Clinical Trials Register

Summary
EudraCT Number:	2011-005419-10
Sponsor's Protocol Code Number:	TRAVOPROSTPR1/2011
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:	2012-03-02
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

2011-005419-10

A.3

Full title of the trial

EVALUATION OF THE THERAPEUTIC EQUIVALENCE OF TRAVOPROST PR AND TRAVATAN. DOUBLE BLIND RANDOMIZED CLINICAL TRIAL IN SUBJECTS AFFECTED BY GLAUCOMA OR INTRAOCULAR HYPERTENSION.

EVALUATION OF THE THERAPEUTIC EQUIVALENCE OF TRAVOPROST PR AND TRAVATAN. DOUBLE BLIND RANDOMIZED CLINICAL TRIAL IN SUBJECTS AFFECTED BY GLAUCOMA OR INTRAOCULAR HYPERTENSION.

A.3.1

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

Valutazione dell’equivalenza terapeutica di Travoprost PR e TravatanR. Studio clinico randomizzato in doppio cieco in pazienti affetti da glaucoma o ipertensione endo-oculare.

A.4.1

Sponsor's protocol code number

TRAVOPROSTPR1/2011

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	PH&T SPA
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	PH&T
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	CRONOS RICERCHE CLINICHE srl
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Via Tonale, 22
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20124
B.5.3.4	Country	Italy
B.5.4	Telephone number	02/67.38.28.69
B.5.5	Fax number	02/67.38.28.68
B.5.6	E-mail	p.minguzzi@cronosrl.net

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	TRAVOPROST PR
D.3.2	Product code	NA
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	Intraocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRAVOPROST
D.3.9.1	CAS number	157283-68-6
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB12613MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.2
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	TRAVATAN*COLL 2,5ML 40MCG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ALCON ITALIA 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	Intraocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRAVOPROST
D.3.9.1	CAS number	157283-68-6
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB12613MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.2
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

Primary open angle glaucoma (POAG) or ocular hypertension (OH)

Glaucoma ad angolo aperto o ipertensione endo-oculare

E.1.1.1

Medical condition in easily understood language

Primary open angle glaucoma (POAG) or ocular hypertension (OH)

Glaucoma ad angolo aperto o ipertensione endo-oculare

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	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 main objective of the study is to assess the therapeutic equivalence of two different formulation of Travoprost PR (Travoprost PR versus Travatan) in the treatment of subjects affected by primary angle glaucoma (POAG) or ocular hypertension (OH) treated for 12 weeks.
Primary end-point will be the change in IOP from baseline in 2 study groups at 12 weeks.

obiettivo principale dello studio la valutazione dell’equivalenza terapeutica di due colliri contenenti Travoprost (Travoprost PR versus Travatan) nel trattamento, per 12 settimane, di soggetti affetti da glaucoma primario ad angolo aperto o da ipertensione oculare.
L’obiettivo primario è la dimostrazione dell’equivalenza terapeutica dei due prodotti in termini di cambiamento della pressione oculare (IOP) al termine delle 12 settimane di trattamento in confronto ai valori basali.

E.2.2

Secondary objectives of the trial

Secondary end-points will be:
•To assess local tolerability of the two formulations, in terms of local adverse events,
•To assess systemic tolerability of the two formulations in terms of changes in vital parameters (arterial blood pressure and heart rate will be registered at each visit), onset of systemic adverse events (registered at each visit) and changes in laboratory parameters (assessed at the entry and at the end of the 12-week treatment),
•To calculate the percentage change in IOP from start to end of 12-week treatment,
•To calculate the reduction in IOP by both formulation, at each time point at baseline and at the end of the 12-week treatment.

Gli obiettivi secondari sono:
•La valutazione della tollerabilità locale dei due prodotti, in termini di eventi avversi locali,
•La valutazione della tollerabilità sistemica dei due prodotti in termini di cambiamento dei parametri vitali (pressione arteriosa e frequenza cardiaca rilevate ad ogni visita), insorgenza di eventi avversi sistemici (registrati ad ogni visita) e variazione dei parametri di laboratorio (valutazioni effettuate alla visita di screening e a quella finale),
•Il calcolo della variazione percentuale della pressione oculare al termine dello studio rispetto ai valori di base,
•Il calcolo della riduzione della pressione oculare nelle diverse ore di misurazione della IOP.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Adult subjects of either sex,
•Subjects affected by unilateral or bilateral POAG or IOH,
•IOP > 21 mm Hg at Randomization visit,
•Subjects who have given written informed consent, consistent with local requirements.

•Soggetti adulti (di età uguale o superiore a 18 anni) di entrambi i sessi,
•Soggetti affetti da glaucoma primario ad angolo aperto o ipertensione uni o bilaterali,
•Pressione oculare (IOP) > 21 mm Hg alla visita di Randomizzazione,
•Soggetti che abbiano fornito il proprio consenso scritto allo studio.

E.4

Principal exclusion criteria

•Subjects affected by closed or slit like anterior chamber angle,
•Positive history for acute angle closure,
•Positive history of argon laser trabeculoplasty within 3 months prior screening (the unlasered eye could be enrolled in the study) or of any ocular filtering surgical intervention (the unoperated eye could be enrolled in the study),
•Ocular surgery or ocular inflammation/infection in either eye within 3 months prior to screening,
•Current use of contact lenses,
•Best corrected visual acuity < 20/200,
•Subjects previously treated with Travoprost PR,
•Subjects concomitantly treated with hypotonic agents,
•Known cardiac conduction defects,
•Decompensate heart failure,
•Reactive airway disease,
•Liver impairment with transaminase levels >3x the upper limit of normal range,
•Hypersensitivity to any of the components of the treatment medication,
•Female subjects of child-bearing potential with a positive pregnancy test;
•Female subjects who are nursing;
•Impossibility to attend all the planned visits and/or to have all the tests foreseen by the protocol performed,
•History of non-compliance, alcoholism or drug abuse,
•Subjects having previously participated in this study or in a clinical trial of an investigational drug within the last 30 days prior to the Screening visit,
•Subject has any condition which, in the opinion of the investigator, could interfere with the study results or be considered detrimental to the subject’s welfare.

•Soggetti affetti da glaucoma a chiusura d’angolo,
•Anamnesi positive per glaucoma ad angolo chiuso,
•Anamnesi positiva per trabeculoplastica laser con argon nei tre mesi precedenti lo screening (l’occhio non trattato può essere valutato nello studio) o per qualsiasi intervento filtrante chirurgico sull’occhio (l’occhio non operato può essere valutato nello studio),
•Intervento chirurgico sull’occhio o infiammazione/infezione oculare nei tre mesi precedenti lo screening,
•Uso di lenti a contatto,
•Acuità visiva corretta < 20/200,
•Soggetti precedentemente trattati con Travoprost,
•Soggetti in trattamento concomitante con farmaci ipotonizzanti,
•Soggetti affetti da difetti della conduzione cardiaca,
•Soggetti affetti da scompenso cardiaco,
•Soggetti affetti da malattie respiratorie,
•Soggetti affetti da insufficienza epatica con livelli di transaminasi 3 volte superiori al limite superiore del range di normalità,
•Anamnesi positiva per ipersensibilità a qualsiasi componente dei farmaci in studio,
•Donne in età fertile con un test di gravidanza positivo,
•Donne in allattamento,
•Impossibilità a presentarsi alle visite previste dal protocollo di studio o di sottoporsi ai controlli previsti,
•Anamnesi positiva per non-compliance, alcolismo o uso di sostanze stupefacenti,
•Soggetti che abbiano, nei precedenti 30 giorni dalla visita di Screening, partecipato ad uno studio o assunto un farmaco sperimentale,
•Soggetti che presentino qualsiasi altra controindicazione allo studio, sulla base delle conoscenze del medico sperimentatore.

E.5 End points

E.5.1

Primary end point(s)

Primary outcome will be the change in IOP from baseline in 2 study groups at 12 weeks.

Il parametro principale di efficacia è la differenza in termini di riduzione della pressione oculare tra i valori osservati al basale rispetto a quelli registrati al termine dello studio (12 settimane) nei due bracci di trattamento.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

Secondary end point(s)

•To assess local tolerability of the two formulations, in terms of local adverse events,
•To assess systemic tolerability of the two formulations in terms of changes in vital parameters (arterial blood pressure and heart rate will be registered at each visit), onset of systemic adverse events (registered at each visit) and changes in laboratory parameters (assessed at the entry and at the end of the 12-week treatment),
•To calculate the percentage change in IOP from start to end of 12-week treatment,
•To calculate the reduction in IOP by both formulation, at each time point recorded.

-Tollerabilità locale dei due IMP in termini di eventi avversi locali.

-Tollerabilità Sistemica dei due IMP verrà valutata in termini di registrazione di eventi avversi riscontro di variazioni dei parametri vitali o degli esami laboratoristici previsti dal protocollo.
-Cambiamento percentuale dell IOP dal basale alla fine delle 12 settimane di trattamento
-Riduzione della IOP ad ogni visita prevista dal protocollo.

E.5.2.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

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

Yes

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)

Yes

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)

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-02.

Yes

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

142

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)

Not applicable

Non applicabile

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

2012-02-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-24

P. End of Trial
P.	End of Trial Status	Completed

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