Clinical Trials Register

Summary
EudraCT Number:	2017-004262-95
Sponsor's Protocol Code Number:	0130A01SA
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:	2021-06-14
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

2017-004262-95

A.3

Full title of the trial

Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment

Studio di fase III, multinazionale, multicentrico, mascherato per lo sperimentatore, randomizzato, con controllo attivo, per confrontare l’efficacia e la sicurezza di DE-130A rispetto a Xalatan® in pazienti con glaucoma ad angolo aperto o ipertensione oculare nel corso di 3 mesi, seguiti da un follow-up di 12 mesi con trattamento a base di DE-130A in aperto

A.3.1

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

International clinical study comparing the efficacy and safety of DE-130A with Xalatan® in patients with glaucoma (high pressure inside the eye).

Studio clinico internazionale per confrontare l’efficacia e la sicurezza di DE-130A rispetto a Xalatan® in pazienti con glaucoma (alta pressione intraoculare)

A.3.2

Name or abbreviated title of the trial where available

International clinical study comparing the efficacy and safety of DE-130A with Xalatan® in patients

Studio clinico internazionale per confrontare l’efficacia e la sicurezza di DE-130A rispetto a Xalat

A.4.1

Sponsor's protocol code number

0130A01SA

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 SAS
B.1.3.4	Country	France
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Santen SAS
B.5.2	Functional name of contact point	Regulatory Affairs EMEA
B.5.3	Address:
B.5.3.1	Street Address	Genavenir IV, 1 rue Pierre Fontaine
B.5.3.2	Town/ city	Evry
B.5.3.3	Post code	90158
B.5.3.4	Country	France
B.5.6	E-mail	regulatoryaffairs@santen.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	n.a.
D.3.2	Product code	[DE-130A]
D.3.4	Pharmaceutical form	Eye lotion, solvent for reconstitution
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	LATANOPROST
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	LATANOPROST
D.3.9.4	EV Substance Code	SUB08409MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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.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	Xalatan 50 micrograms/ml eye drops, solution
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Xalatan 50 micrograms/ml eye drops, solution
D.3.2	Product code	[n.a.]
D.3.4	Pharmaceutical form	Eye lotion, solvent for reconstitution
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	LATANOPROST
D.3.9.2	Current sponsor code	N.A.
D.3.9.4	EV Substance Code	SUB08409MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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

Open-Angle Glaucoma or Ocular Hypertension

Laucoma ad angolo aperto oppure ipertensione oculare

E.1.1.1

Medical condition in easily understood language

Glaucoma

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	10030043
E.1.2	Term	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

To demonstrate that the intraocular pressure (IOP) reducing effect of
DE-130A (latanoprost 50 µg/ml preservative-free eye drops emulsion) is
non-inferior to that of Xalatan® [latanoprost 50 µg/ml Benzalkonium
Chloride (BAK)-preserved eye drops solution] in patients with Open-
Angle Glaucoma (OAG) or Ocular Hypertension (OHT) at Week 12
without using any rescue medication(s).

Dimostrare che gli effetti ipotensivi di DE-130A (latanoprost 50 mcg/ml collirio,
emulsione senza conservanti) sulla pressione intraoculare (Intra-Ocular Pressure, IOP) non
sono inferiori a quelli di Xalatan® (latanoprost 50 mcg/ml collirio, soluzione con cloruro di
benzalconio (BAK) come conservante) in pazienti con glaucoma ad angolo aperto (Open-
Angle Glaucoma, OAG) o ipertensione oculare (Ocular Hypertension, OHT) alla Settimana
12, senza l’uso di farmaci di soccorso.

E.2.2

Secondary objectives of the trial

- To compare the effect on improving OSD signs and symptoms between treatment groups [for the FAS population and by corneal fluorescein staining (CFS) subgroups, baseline study eye CFS = 1 vs. CFS = 2, modified Oxford scale] over 3 months (Period 1).
- To estimate the effect of DE-130A on OSD signs and symptoms for the Open-Label population and by OSD subgroups up to 15 months (Periods 1 & 2).
- To compare the efficacy on IOP reduction between treatment groups for the FAS population and OSD subgroups over 3 months (Period 1).
- To estimate the effect of DE-130A on IOP for the Open-Label population and by OSD subgroups up to 15 months (Periods 1 & 2).
- To evaluate the local ocular tolerance and systemic safety of the two treatments over 3 months (Period 1, Safety population).
- To estimate the local ocular tolerance and systemic safety of DE-130A up to 15 months (Periods 1 & 2, Open-Label population).

• Confrontare l’effetto sul miglioramento dei segni e dei sintomi tra i gruppi di trattamento (per la popolazione del set di analisi completo e per i sottogruppi della colorazione con fluoresceina corneale, CFS=1 rispetto a CFS =2 dell’occhio di analisi al basale, scala Oxford modificata) nell’arco di 3 m(Per. 1)
• Per stimare l’effetto di DE-130A sui segni e sintomi della OSD per la popolazione in aperto e secondo il sottogruppo OSD fino a 15 m(Per. 1 e 2)
• Confrontare l’efficacia della riduzione della pressione intraoculare tra gruppi di trattamento per la popolazione FAS e i sottogruppi OSD nell’arco di 3 m(Per. 1)
• Stimare l’effetto di DE-130A sulla IOP per la popolazione in aperto e secondo il sottogruppo OSD fino a 15 m Per. 1 e 2)
• Stimare la tolleranza oculare locale e la sicurezza sistemica dei due trattamenti nell’arco di 3 m(Per. 1, popolazione di sicurezza)
• Stimare la tolleranza oculare locale e la sicurezza sistemica di DE-130A fino a 15 m(Per. 1 e 2, pop. in aperto)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Male or female, 18 years of age or older
-Diagnosis of OAG (primary open angle glaucoma, pseudo exfoliative glaucoma, or pigmentary glaucoma), or OHT in eligible eye(s) currently on monotherapy.
-Unilateral OAG, or OHT are permissible as long as the physician does not anticipate significant IOP changes to the fellow eye that would require treatment during the duration of the study.
-Current treatment with monotherapy for OAG or OHT with a controlled IOP = 18 mmHg in each eye (pre-washout).
-Stable visual field.
-Post-washout IOP = 22 mmHg in at least one eye
-Post-washout IOP = 32 mmHg in both eyes

- Sesso maschile o femminile, almeno 18 anni di età
- Diagnosi di OAG (glaucoma primario ad angolo aperto, pseudo glaucoma esfoliativo, o glaucoma pigmentario) oppure OHT nell’occhio/i idoneo/i attualmente in monoterapia.
- Un’eventuale OAG unilaterale o OHT sono ammissibili a condizione che il medico non anticipi cambiamenti significativi della pressione intraoculare nell’occhio controlaterale che andrebbero trattati durante lo studio.
- Trattamento corrente in monoterapia per OAG or OHT con una pressione intraoculare = 18 mmHg in ogni occhio (pre-washout).
- Campo visivo stabile
- Pressione intraoculare = 22 mmHg dopo il periodo di washout
Pressione intraoculare = 32 mmHg dopo il periodo di washout

E.4

Principal exclusion criteria

-Any form of glaucoma other than primary open angle glaucoma, pseudo exfoliative glaucoma, and pigmentary glaucoma in either eye.
-IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 32 mmHg in either eye.
-Current treatment for glaucoma with a fixed-combination therapy or more than one drug or with an oral drug within 6 months prior to screening.
-Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer in either eye.
-Central corneal thickness = 480 µm or = 600 µm in either eye (historical value or at the screening visit)
-Significant visual field loss (absolute defect in the 10° central point or mean deviation worse than -12 dB) or progressive field loss during the year before screening.
-Significant optic nerve abnormality, other than glaucomatous abnormalities in the opinion of the investigator as determined by ophthalmoscopy.
-Significant changes of the optic neuropathy (e.g. increase cupping since the last examination, optic nerve hemorrhage)
-Inability to visualize the patient's optic nerve.
-Gonioscopy consistent with potential angle closure glaucoma.
-Patients with severe blepharitis and/or Meibomian Gland Disease (MGD). Patients enrolled with mild to moderate blepharitis and/or MGD should be treated as appropriate during the study
-Any active ocular disease
-Intraocular surgery within 6 months prior to screening.
-Past history of any filtering surgery for glaucoma.
-Refractive surgery of any type within 1 year prior to screening
-Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP

- Qualsiasi forma di glaucoma diverso dal glaucoma primario ad angolo aperto, dal glaucoma pseudo esfoliativo e dal glaucoma pigmentario in uno degli occhi
- Pressione intraoculare > 32 mmHg in uno degli occhi.in qualsiasi momento durante le visite di screening o basale (Visite 1 o 2)
- Trattamento attuale per il glaucoma con una terapia combinatoria fissa o con diversi farmaci in uno degli occhi, oppure con un farmaco assunto per via orale nei 6 mesi antecedenti lo screening.
- Anomalie corneali che potrebbero interferire con determinazioni accurate della pressione intraoculare per mezzo di un tonometro ad applanazione in uno degli occhi.
- Spessore della parte centrale della cornea = 480 µm o = 600 µm in uno degli occhi (valore storico oppure rilevato durante la visita di screening)
- Perdita significativa del campo visivo (difetto assoluto entro 10° dal punto centrale della cornea o deviazione media peggiore di -12 dB) oppure perdita progressiva del campo nell’anno antecedente lo screening in uno degli occhi.
- Anomalie significative a carico del nervo ottico, tranne le anomalie glaucomatose, a parere dello sperimentatore, determinate oftalmoscopicamente in uno degli occhi.
- Cambiamenti significativi della neuropatia ottica (ad es., aumento della coppettazione dall’ultimo esame, emorragia del nervo ottico) in uno degli occhi.
- Incapacità di visualizzare il nervo ottico del paziente in uno degli occhi
- Gonioscopia corrispondente alla possibilità di glaucoma ad angolo chiuso in uno degli occhi.
- Pazienti con blefarite grave e/o malattia delle ghiandole di Meibomio (Meibomian Gland Disease, MGD) grave. I pazienti arruolati affetti da blefarite e/o MGD da lieve a moderata devono essere trattati adeguatamente nel corso dello studio in uno degli occhi.
- Qualsiasi patologia oculare
- Intervento chirurgico intraoculare nei 6 mesi antecedenti lo screening in uno degli occhi.
- Qualsiasi precedente intervento di chirurgia filtrante per il glaucoma in uno degli occhi.
- Chirurgia refrattiva di qualsiasi tipo nell’anno antecedente lo screening in uno degli occhi.
- Previsione di un’alterazione della terapia cronica con agenti noti per il loro rilevante effetto sulla IOP, o introduzione di tali agenti

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the change in Intra Ocular Pressure
(IOP)

E.5.1.1

Timepoint(s) of evaluation of this end point

Efficacy:
The change from baseline in peak (9:00 am ± 1 hour) and
trough (4:00 pm ± 1 hour) IOPs, respectively, at Week 12 between the
two treatment groups in the study eye.

Efficacia:
L’endpoint di efficacia primario è la variazione tra i due gruppi di trattamento, rispetto al basale, rispettivamente della pressione intraoculare massima (09:00 ± 1 ora) e minima (16:00 ± 1 ora) nell’occhio di analisi alla Settimana 12.

E.5.2

Secondary end point(s)

The key secondary endpoints are:
•Change in Corneal Fluorescein Staining (CFS)
•Change in OSD symptom score
Sicurezza e tollerabilità:
•The incidence and severity of ocular and systemic adverse events
•Best-corrected distance visual acuity
•Slit lamp examination (lashes, anterior chamber and lens).
•Dilated fundoscopy

Gli endpoint secondari essenziali sono:
• Variazione del punteggio CFS
• Variazione rispetto al basale del punteggio dei sintomi della OSD
Sicurezza e tollerabilità:
• Incidenza e gravità degli eventi avversi oculari e sistemici
• Migliore acuità visiva da lontano corretta
• Esame con lampada a fessura (ciglia, camera anteriore e cristallino).
• Esame del fondo oculare con dilatazione

E.5.2.1

Timepoint(s) of evaluation of this end point

•Change from baseline in CFS score at Week 12
•Change from baseline in OSD symptom score (average of 3 symptoms)
at Week 12
Safety and Tolerability:
At all visits and for each treatment (Period 1) and for the Open-Label population for DE-130A at all visits (Period 2 and Periods 1 & 2 combined),

• Variazione del punteggio CFS rispetto al basale alla Settimana 12
• Variazione rispetto al basale del punteggio dei sintomi (media di 3 sintomi) alla Settimana 12
Safety and Tolerability:
in corrispondenza di tutte le visite e per ogni trattamento (Periodo 1) nonché nella popolazione in aperto per DE-130A, in corrispondenza di tutte le visite (Periodo 2 e Periodi 1 e 2 combinati)

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)

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Period 1: investigator-masked; Period 2: open-label

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

Information not present in EudraCT

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

Korea, Republic of

Russian Federation

Estonia

Finland

France

Germany

Italy

Poland

Spain

United Kingdom

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

305

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

290

F.4.2.2

In the whole clinical trial

380

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

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

2019-03-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-10-26

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