Clinical Trials Register

Summary
EudraCT Number:	2014-005273-37
Sponsor's Protocol Code Number:	201450
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:	2021-01-13
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

2014-005273-37

A.3

Full title of the trial

A phase IV study on changes in ocular signs and symptoms in patients with with ocular hypertension or open-angle glaucoma switched from Ganfort¿
eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom¿ eye drops (tafluprost 0.0015%/timolol 0.5%)

Studio di fase IV sulle alterazioni di segni e sintomi oculari in pazienti affetti da ipertensione oculare o glaucoma ad angolo aperto che sono passati dal collirio Ganfort¿ (bimatoprost 0,03% e timololo 0,5%) al collirio Taptiqom¿ (tafluprost 0,0015% e timololo 0,5%)

A.3.1

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

A clinical trial on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from Ganfort¿
eye drops to Taptiqom¿ eye drops.

Studio clinico sulle alterazionidi segni e sintomi oculari in pazienti affetti da ipertensione oculare o glaucoma ad angolo aperto che sono passati dal collirio Ganfort¿ (bimatoprost 0.03% e timolol 0.5%)
al collirio Taptiqom¿ (tafluprost 0.0015% e timolol 0.5%)

A.3.2

Name or abbreviated title of the trial where available

Clinical Trial on changes in ocular signs and symptoms in patients with ocular hypertension or open-

Studio clinico sulle alterazioni di segni e sintomi oculari in pazienti con ipertensione oculare o g

A.4.1

Sponsor's protocol code number

201450

A.5.4

Other Identifiers

Name:

201450

Number:

201450

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	SANTEN OY
B.1.3.4	Country	Finland
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	Santen OY
B.4.2	Country	Finland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Santen Oy
B.5.2	Functional name of contact point	Manager Clinical Research
B.5.3	Address:
B.5.3.1	Street Address	Niittyhaankatu 20
B.5.3.2	Town/ city	Tampere
B.5.3.3	Post code	33720
B.5.3.4	Country	Finland
B.5.4	Telephone number	358 50 3502765
B.5.5	Fax number	0
B.5.6	E-mail	anne.pielismaa@santen.fi

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	LOYADA - "15 MICROGRAMMI/ML + 5 MG/ML COLLIRIO, SOLUZIONE" 90 X 0,3ML CONTENITORI MONODOSE IN LDPE
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD ITALIA S.R.L.
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	Loyada¿
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	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIMOLOLO MALEATO
D.3.9.1	CAS number	26921-17-5
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Timololo Maleate
D.3.9.4	EV Substance Code	SUB04876MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TAFLUPROST
D.3.9.1	CAS number	209860-87-7
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Tafluprost
D.3.9.4	EV Substance Code	SUB30776
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0
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	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	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 or Ocular Hypertension

Glaucoma o ipertensione oculare

E.1.1.1

Medical condition in easily understood language

Glaucoma or Ocular Hypertension

Glaucoma o 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	20.0
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.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10074026
E.1.2	Term	Exfoliation glaucoma
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
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.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to investigate
whether changes in ocular signs or symptoms occur when patients with OHT or OAG (POAG or PEX)
are switched from Ganfort¿ eye drops (FDC of bimatoprost 0.03% and timolol 0.5%) to Taptiqom¿ eye drops (FDC of tafluprost 0.0015% and timolol 0.5%).

Il presente studio ha l'obiettivo di verificare l¿insorgenza di alterazioni di segni o sintomi oculari
quando i pazienti passano dal collirio Ganfort¿ FDC (Fixed Dose Combination[Combinazione a Dose Fissa]) di bimatoprost 0,03% e timololo 0,5% al collirio Taptiqom¿ (FDC di tafluprost 0,0015% e timololo 0,5%).

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged 18 years or more
2. A diagnosis of ocular hypertension or open-angle glaucoma (either
POAG or PEX) in one or both eyes, for which the patient has been
regularly using Ganfort® in the evening for at least 4 weeks before
Screening.
3. In the Screening visit evaluation, the presence of:
- conjunctival redness/hyperemia at least in one treated eye
AND
- at least one ocular symptom considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye
sensation)
4. A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes
5. Have provided a written informed consent and are willing to follow instructions

1.Soggetti di età uguale o maggiore di 18 anni
2. Diagnosi di ipertensione oculare o glaucoma ad angolo aperto (sia POAG (Glaucoma primario ad angolo aperto) o PEX (Glaucoma pseuoesfoliativo) ) in uno o entrambi gli occhi, per la quale il
paziente ha regolarmente utilizzato Ganfort® la sera per almeno 4 settimane prima dello Screening.
3. Alla visita di screening, la presenza di:
- Arrossamento congiuntivale / iperemia almeno in uno degli occhi trattati
e
- Almeno un sintomo oculare considerato per entrambi gli occhi (irritazione / bruciore / prurito, sensazione di corpo estraneo, lacrimazione, prurito o
sensazione di secchezza oculare)
4. Un miglior punteggio corretto del test di acuita visiva ETDRS di +0,6 logMAR o migliore in
entrambi gli occhi
5. Pazienti disposti fornire un consenso informato scritto ed essere disposti a seguire le istruzioni dello studio

E.4

Principal exclusion criteria

1. Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
2. Use of more than two active medicinal agents to treat glaucoma/OH during the past six months prior to Screening
3. Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
4. Any corneal abnormality or other condition preventing reliable applanation tonometry,including prior refractive eye surgery
5. IOP greater than 21 mmHg in treated eye(s) at Screening/Baseline visit
6. Use of preserved eye drops (other than Ganfort®) including artificial tears at screening or within two weeks prior to screening visit
7. Diagnosis of angle-closure glaucoma or secondary glaucoma other than PEX in either eye
8. Suspected contraindication to tafluprost or timolol therapy (low heart rate or clinically relevant low blood pressure for age, chronic obstructive
pulmonary disease, bronchial asthma, strong tendency to bronchospasm, certain cardiac arrhythmias or uncontrolled congestive heart failure)
9. Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening in eye(s) to be treated with study medication
10. Use of contact lenses at Screening or during the study
11. Any ocular, systemic or psychiatric disease/conditio that may put the patient at a significant risk or may confound the study results as judged by the investigator
12. Current alcohol or drug abuse
13. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days prior to Screening

1. Pazienti di sesso femminile in stato di gravidanza, allattamento o che stanno programmando una gravidanza, o pazienti di sesso femminile in età fertile che non utilizzano un metodo affidabile di contraccezione
2. L'uso di più di due agenti attivi medicinali per trattare il glaucoma / ipertensione oculare (OH)
nel corso degli ultimi sei mesi prima dello screening
3. Angolo anteriore della camera in entrambi gli occhi da trattare al di sotto del grado 2
secondo la classificazione Schaffer come da misurazione mediante gonioscopia
4. Qualsiasi anomalia corneale o altra condizione che previene un’affidabile tonometria ad appianamento, compresa una precedente chirurgia refrattiva dell'occhio
5. IOP maggiore di 21 mmHg nell'occhio trattato (s) alla visita di Screening / Basale
6. Utilizzo di gocce per il mantenimento dell'occhio (diversi Ganfort®) comprese lacrime artificiali allo screening o entro due settimane precedenti la visita di screening
7. Diagnosi di glaucoma ad angolo chiuso o glaucoma secondario che non sia di tipo PEX in entrambi gli occhi
8. Controindicazione Sospetta a Tafluprost o terapia con timololo (bassa frequenza cardiaca o
bassa pressione arteriosa clinicamente significativa per l’età, malattia polmonare cronica ostruttiva, asma bronchiale, forte tendenza a broncospasmo,
alcune aritmie cardiache o insufficienza cardiaca congestizia non controllata)
9. Chirurgia di filtrazione del glaucoma o qualsiasi altro intervento chirurgico oculare (incluse
procedure con laser) entro 6 mesi precedenti lo screening nell’occhio/i da trattare
con il farmaco in studio
10. Uso di lenti a contatto allo screening o durante lo studio
11. Qualsiasi malattia oculare, sistemica o psichiatrica che può mettere il paziente a un rischio significativo o possa confondere i risultati dello studio a giudizio dallo sperimentatore
12. Uso corrente di alcool o abuso di droghe
13. Partecipazione in un'altra sperimentazione clinica che coinvolge con farmaco / dispositivo o eventuale partecipazione negli ultimi 30 giorni precedenti lo screening

E.5 End points

E.5.1

Primary end point(s)

Change from screening in conjunctival
redness/hyperemia at week 12

Variazione del rossore/iperemia congiuntivale dallo screening alla settimana 12

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

Secondary end point(s)

Change from screening in ocular symptoms upon non-instillation at week 12.
Quality of Life

Variazione nei segni oculari (diversi dal rossore/iperemia congiuntivale) alla settimana 12 rispetto allo screening.
Qualit¿ della vita

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

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

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

LPLV

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:

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

120

F.4.2.2

In the whole clinical trial

120

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)

None

Nessuno

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

2015-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-02

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

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