Clinical Trials Register

Summary
EudraCT Number:	2014-003186-24
Sponsor's Protocol Code Number:	192024-092
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:	2015-01-22
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

2014-003186-24

A.3

Full title of the trial

The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

L’efficacia e la sicurezza di Bimatoprost SR in pazienti con glaucoma ad angolo aperto o ipertensione oculare

A.3.1

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

The Efficacy and Safety of Bimatoprost SR in Patients with Open-angle Glaucoma or Ocular Hypertension

L’efficacia e la sicurezza di Bimatoprost SR in pazienti con glaucoma ad angolo aperto o ipertensione oculare

A.4.1

Sponsor's protocol code number

192024-092

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02247804

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	Allergan Limited
B.1.3.4	Country	United Kingdom
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	Allergan Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Allergan Limited
B.5.2	Functional name of contact point	Allergan Limited EU Regulatory Dept
B.5.3	Address:
B.5.3.1	Street Address	1st Floor Marlow International, The Parkway
B.5.3.2	Town/ city	Marlow, Buckinghamshire
B.5.3.3	Post code	SL7 1YL
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441628494 444
B.5.5	Fax number	+441628494 449
B.5.6	E-mail	ml-ctrg@allergan.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	Bimatoprost SR
D.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracameral 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.3.9.4	EV Substance Code	SUB12470MIG
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	10
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	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	Bimatoprost SR
D.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracameral 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.3.9.4	EV Substance Code	SUB12470MIG
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	15
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	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	Timolol
D.3.2	Product code	8770X
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	8770X
D.3.9.3	Other descriptive name	TIMOLOL
D.3.9.4	EV Substance Code	SUB04875MIG
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	5
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
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
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Open-angle Glaucoma and Ocular Hypertension

Glaucoma ad angolo aperto e Ipertensione oculare

E.1.1.1

Medical condition in easily understood language

Glaucoma and increased pressure inside the eye (Ocular hypertension)

Glaucoma e aumento della pressione all’interno dell’occhio (ipertensione 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	17.1
E.1.2	Level	HLGT
E.1.2	Classification code	10018307
E.1.2	Term	Glaucoma and ocular hypertension
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10030043
E.1.2	Term	Ocular hypertension
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
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 evaluate the intraocular pressure (IOP)-lowering efficacy and safety
of 2 dose strengths of Bimatoprost SR in patients with open-angle glaucoma
(OAG) or ocular hypertension (OHT) after initial and repeated administrations

Valutare l’efficacia e la sicurezza di 2 dosaggi di Bimatoprost SR nel ridurre la pressione intracoulare (IOP) in pazienti con glaucoma ad angolo aperto (OAG) o ipertensione oculare (OHT), dopo somministrazioni iniziali e ripetute

E.2.2

Secondary objectives of the trial

not applicable

Not Applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Key Inclusion Criteria:
• Written informed consent has been obtained
• In the opinion of the investigator, based on prior use or on IOP rebound (elevation) during the washout period, patient is a responder to IOP lowering by topical prostamides, prostaglandins, or prostaglandin analogs
• The iridocorneal angle inferiorly in the study eye must be confirmed as being qualified by Reading Center AS-OCT assessment
• By the Baseline visit, the final central endothelial cell density in both eyes must be confirmed as being qualified by Reading Center assessment
• Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, and both eyes require IOP-lowering treatment
• In the investigator’s opinion, either eye can be treated adequately with timolol eye drops as the sole therapy
• In both eyes, at the baseline visit: Hour 0 IOP of ≥ 22 mm Hg and ≤ 32 mm Hg, with difference between eyes of ≤ 5 mm Hg
• In both eyes at Hour 2 at the baseline visit, IOP ≥ 19 mm Hg and ≤ 32 mm Hg

•È stato ottenuto il consenso informato scritto.
•Secondo il giudizio dello sperimentatore, in base all'uso precedente o all'IOP rebound (rialzo) durante il periodo di washout, il paziente è un responder in termini di riduzione dell'IOP mediante somministrazione topica di prostamidi, prostaglandine o analoghi delle prostaglandine
•L'angolo iridocorneale nella parte inferiore dell'occhio dello studio deve essere confermato come qualificato mediante valutazione AS-OCT del centro di lettura.
•Alla visita iniziale, la densità delle cellule endoteliali centrali in entrambi gli occhi deve essere confermata come qualificata mediante valutazione del centro di lettura
•Diagnosi di OAG (OAG primario, glaucoma pseudoesfoliativo, glaucoma pigmentario) o OHT in ciascun occhio e necessità di trattamento antipertensivo oculare in entrambi gli occhi
•Secondo il giudizio dello sperimentatore, un occhio può essere trattato adeguatamente con collirio a base di timololo come unica terapia
•In entrambi gli occhi, alla visita iniziale: IOP ora 0 ≥ 22 mm Hg e ≤ 32 mm Hg, con una differenza tra gli occhi ≤ 5 mm Hg
•In entrambi gli occhi all'ora 2 della visita iniziale, IOP ≥ 19 mm Hg e ≤ 32 mm Hg

E.4

Principal exclusion criteria

History of cataract surgery in the study eye resulting in anterior chamber intraocular lens implant (IOL), phakic IOL, sulcus IOL, aphakia, or complications (eg, a posterior capsular tear [with or without vitreous loss], iris trauma, etc)
• In the investigator’s opinion, patient is nonresponsive to topical ophthalmic beta-blockers
• Contraindications to beta-blocker therapy

• Storia di chirurgia per la cataratta nell'occhio dello studio con impianto di lente intraoculare (IOL) nella camera anteriore, IOL fachica, IOL nel solco, afachia o complicanze (per es., lacerazione della capsula posteriore [con o senza perdita vitreale], trauma dell'iride, ecc.)
•Secondo il giudizio dello sperimentatore, il paziente non risponde a betabloccanti oftalmici topici
•Controindicazioni alla terapia con betabloccanti

E.5 End points

E.5.1

Primary end point(s)

Study eye time-matched IntraOcular Pressure change from baseline (follow-up minus time-matched baseline) at each hour evaluated (Hours 0 and 2).

Cambiamento rispetto al basale della pressione intraoculare dell’occhio in studio rilevata in relazione al tempo (follow-up meno basale rilevato al tempo corrispondente) ad ogni ora valutata (Ore 0 e 2)

E.5.1.1

Timepoint(s) of evaluation of this end point

Mean IOP change from baseline will be compared between each Bimatoprost SR dose strength and timolol for each hour (Hours 0 and 2) using the ITT population. The comparisons at Week 12 will be considered the primary analysis. IOP evaluations will occur at 2 timepoints: Hour 0 (08:00 ± 1 hour) and Hour 2 (Hour 0 + 2 hours [± 30 min]), and on Days 2; 4 and 8 after each administration and at Weeks 2, 6, 12, 15, 18, 22, 28, 31, 34, 38, 44, 48, and 52

Il cambiamento medio della IOP rispetto al basale verrà confrontato tra ciascun dosaggio di Bimatoprost SR e timololo per ogni ora (Ore 0 e 2) utilizzando la popolazione ITT. I confronti alla Settimana 12 saranno considerati l’analisi primaria. Le valutazioni della IOP saranno effettuate in 2 momenti: Ora 0 (08:00 ± 1 ora) e Ora 2 (Ora 0 + 2 ore [± 30 min]), e ai Giorni 2, 4 e 8 dopo ogni somministrazione e alle Settimane 2, 6, 12, 15, 18, 22, 28, 31, 34, 38, 44, 48 e 52

E.5.2

Secondary end point(s)

time-matched lowering of IntraOcular Pressure.

Abbassamento della Pressione Intraoculare rilevato in relazione al tempo

E.5.2.1

Timepoint(s) of evaluation of this end point

at scheduled visits (Weeks 2, 6, and 12) and hours for (1) time-matched IOP and (2) time-matched IOP change from baseline.

In occasione delle visite (Settimane 2, 6, e 12) e ore programmate per (1) IOP rilevata in relazione al tempo e (2) cambiamento della IOP rilevata in relazione al tempo rispetto al basale

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

Yes

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Canada

Colombia

Czech Republic

Egypt

Germany

Italy

Korea, Republic of

Malaysia

Netherlands

New Zealand

Russian Federation

Saudi Arabia

Singapore

South Africa

Thailand

Turkey

United Kingdom

United States

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

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.1.1.1

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

234

F.4.2.2

In the whole clinical trial

600

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)

patient will return to their standard of care treatment as determined by the physician after completion of the trial

Dopo la conclusione della sperimentazione, i pazienti riprenderanno i loro trattamenti standard di cura come stabilito dal medico

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

2015-03-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-10

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

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