Clinical Trials Register

Summary
EudraCT Number:	2016-002439-14
Sponsor's Protocol Code Number:	SHP640-301
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-06-08
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

2016-002439-14

A.3

Full title of the trial

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and
Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis

Studio in doppio cieco di fase 3, multicentrico, randomizzato volto a valutare l¿efficacia clinica e la sicurezza della sospensione oftalmica SHP640 (PVP-iodio 0,6% e desametasone 0,1%) rispetto a PVP-iodio e placebo nel trattamento della congiuntivite da adenovirus

A.3.1

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

SHP640 in the Treatment of Adenoviral Conjunctivitis

SHP640 nel trattamento della congiuntivite adenovirale

A.3.2

Name or abbreviated title of the trial where available

SHP640 in the Treatment of Adenoviral Conjunctivitis

SHP640-301 nel trattamento della congiuntivite adenovirale

A.4.1

Sponsor's protocol code number

SHP640-301

A.5.4

Other Identifiers

Name:

75,723

Number:

SHP640-301

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/313/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SHIRE HUMAN GENETIC THERAPIES, INC
B.1.3.4	Country	United States
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	Shire Human Genetic Therapies, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Shire Human Genetic Therapies, Inc.
B.5.2	Functional name of contact point	Sr. Clinical Project Manager
B.5.3	Address:
B.5.3.1	Street Address	300 Shire Way
B.5.3.2	Town/ city	Lexington
B.5.3.3	Post code	MA 02421
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 781-482-2008
B.5.5	Fax number	nd
B.5.6	E-mail	kdanis@shire.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	SHP640
D.3.2	Product code	SHP640
D.3.4	Pharmaceutical form	Eye drops, suspension
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	Dexamethasone
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	SRD006094
D.3.9.3	Other descriptive name	DEXAMETHASONE, MICRONIZED, USP
D.3.9.4	EV Substance Code	SUB171170
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	Povidone Iodine
D.3.9.1	CAS number	25655-41-8
D.3.9.2	Current sponsor code	SRD006095, PVP-I
D.3.9.4	EV Substance Code	SUB14999MIG
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.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	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	PVP-I
D.3.2	Product code	PVP-I
D.3.4	Pharmaceutical form	Eye drops, suspension
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	Povidone Iodine
D.3.9.1	CAS number	25655-41-8
D.3.9.2	Current sponsor code	SRD006095, PVP-I
D.3.9.4	EV Substance Code	SUB14999MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
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
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Adenoviral Conjunctivitis

Congiuntivite adenovirale

E.1.1.1

Medical condition in easily understood language

pink eye

Occhi rosa

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10001257
E.1.2	Term	Adenoviral conjunctivitis
E.1.2	System Organ Class	10021881 - Infections and infestations

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 primary objective of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival
injection and watery conjunctival discharge)compared with placebo in the treatment of subjects with adenoviral conjunctivitis in the study eye
at Visit 3 (Day 6).

L¿obiettivo principale di questo studio ¿ valutare l¿efficacia di SHP640 sulla base della risoluzione clinica (definita come assenza di iniezione congiuntivale bulbare e secrezione congiuntivale acquosa) rispetto al placebo nel trattamento di soggetti con congiuntivite da adenovirus nell¿occhio oggetto di studio alla Visita 3 (Giorno 6).

E.2.2

Secondary objectives of the trial

Key secondary objectives:
- To evaluate the efficacy of SHP640 based on clinical resolution
compared with PVP-I in the study eye at Visit 3 (D6).
- To evaluate the efficacy of PVP-I based on adenoviral eradication
(defined as negative cell culture-immunofluorescence assay [CC-IFA])
compared with placebo in the study eye at Visit 2 (D3).
- To evaluate the efficacy of SHP640 based on adenoviral eradication
compared with placebo in the study eye at Visit 3 (D6).
- To evaluate the efficacy of SHP640 based on adenoviral eradication
compared with PVP-I in the study eye at Visit 3 (D6).
- To evaluate the efficacy of PVP-I based on clinical resolution compared
with placebo in in the study eye at Visit 3 (D6).

- Valutare l¿efficacia di SHP640 sulla base della risoluzione clinica rispetto a PVP-I nell¿occhio oggetto di studio alla Visita 3 (G6).
- Valutare l¿efficacia di PVP-I sulla base dell¿eradicazione dell¿adenovirus (definita come saggio di immunofluorescenza-coltura cellulare negativa [CC-IFA]) rispetto al placebo nell¿occhio oggetto di studio alla Visita 2 (G3).
- Valutare l¿efficacia di SHP640 sulla base dell¿eradicazione dell¿adenovirus rispetto al placebo nell¿occhio oggetto di studio alla Visita 3 (G6).
- Valutare l¿efficacia di SHP640 sulla base dell¿eradicazione dell¿adenovirus rispetto a PVP-I nell¿occhio oggetto di studio alla Visita 3 (G6).
- Valutare l¿efficacia di PVP-I sulla base della risoluzione clinica rispetto al placebo nell¿occhio oggetto di studio alla Visita 3 (G6).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Main Inclusion Criteria:
3. Subjects of any age at Visit 1 (Note: subjects <3 months of age at
Visit 1 must have been full-term, ie =37 weeks gestational age at birth).
4. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at
least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by
the presence of the following minimal clinical signs and symptoms in
that same eye:
- Report presence of signs and/or symptoms of adenoviral conjunctivitis
for = 3 days prior to Visit 1- Bulbar conjunctival injection: a grade of =1 (mild) on a 0-4 Bulbar
Conjunctival Injection Scale.
- Watery conjunctival discharge: a grade of =1 (mild) on a 0-3 Watery
Conjunctival Discharge Scale
6. Be willing to discontinue contact lens wear for the duration of the
study.
Full list of Inclusion criteria can be found in the protocol.

3. Soggetti di qualsiasi età alla Visita 1 (Nota: i soggetti di età <3 mesi alla Visita 1 devono essere nati a termine, ovvero età gestazionale =37 settimane alla nascita).
4. Presentare positività al test AdenoPlus® alla Visita 1 in almeno 1 occhio.
5. Presentare una diagnosi clinica di sospetta congiuntivite da adenovirus in almeno 1 occhio (lo stesso occhio con test AdenoPlus positivo) confermata dalla presenza dei seguenti sintomi e segni clinici minimi nello stesso occhio:
- Presenza di segni e/o sintomi di congiuntivite da adenovirus per =3 giorni prima della Visita 1
- Iniezione congiuntivale bulbare: grado =1 (lieve) su una scala di valutazione dell’iniezione congiuntivale bulbare da 0 a 4.
- Secrezione congiuntivale acquosa: grado =1 (lieve) su una scala di valutazione della secrezione congiuntivale acquosa da 0 a 3
6. Disponibilità a interrompere l’uso delle lenti a contatto per tutta la durata dello studio.
L’elenco completo dei criteri di inclusione è reperibile nel protocollo.

E.4

Principal exclusion criteria

1. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory
assessments, per investigator's discretion.
2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete
the study, or any condition that presents undue risk from the investigational product or procedures.
3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated
ingredients.
6. Have a history of ocular surgical intervention within =6 months prior to Visit 1 or planned for the period of the study.
7. Have a preplanned overnight hospitalization during the period of the study.
8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
9. Have presence of corneal subepithelial infiltrates at Visit 1.
10. Have active or history of ocular herpes.
11. Have at enrollment or within =30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-adenoviral ocular infection (eg, bacterial, fungal,
acanthamoebal, other or parasitic).
12. Neonates or infants (ie. subjects less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted
prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
13. Neonates or infants (ie. subjects less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of
delivery or any history of genital herpes.
14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
15. Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study
variables.
16. Be a known intraocular pressure (IOP) steroid responder, have a known history of glaucoma, be a glaucoma suspect, or have a known history of an elevated IOP > 21 mmHg.
17. Have any known clinically significant optic nerve defects.
18. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome;
presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
19. Presence of significant, active condition in the posterior segment which requires invasive treatment (eg, intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study
participation period.Full list of Exclusion criteria can be found in the protocol.

1. Patologia in corso o ricorrente tale da alterare l’azione, l’assorbimento o l’esito del prodotto sperimentale oppure le valutazioni cliniche o di laboratorio, secondo il parere dello sperimentatore.
2. Anamnesi attuale o rilevante di malattia fisica o psichiatrica, qualsiasi disturbo medico che potrebbe probabilmente impedire al soggetto di completare lo studio o qualsiasi condizione che presenti un inutile rischio associato al prodotto sperimentale o alle procedure.
3. Nota o sospetta intolleranza o ipersensibilità al prodotto sperimentale, ai composti strettamente correlati o a uno qualsiasi degli ingredienti indicati.
6. Anamnesi di intervento chirurgico oculare nei =6 mesi precedenti la Visita 1 o intervento pianificato durante il periodo dello studio.
7. Ricovero in ospedale con degenza notturna pre-pianificato durante il periodo dello studio.
8. Presenza di qualsiasi infiammazione intraoculare, corneale o congiuntivale (per es. uveite, irite, cheratite ulcerativa, blefarocongiuntivite cronica), diversa dalla congiuntivite da adenovirus.
9. Presenza di infiltrati corneali subepiteliali alla Visita 1.
10. Herpes oculare pregressa o in fase attiva.
11. Al momento dell’arruolamento o entro =30 giorni dalla Visita 1, presentazione clinica più coerente con la diagnosi di allergia oculare, congiuntivite tossica o infezione oculare non causata da adenovirus (per es. batterica, fungina, da acanthamoeba, di altra natura o parassitica).
12. Neonati o lattanti (ovvero soggetti di età inferiore a 12 mesi) con congiuntivite da gonococco, clamidia, herpes o di natura chimica sospetta o confermata (sulla base del risultato di qualsiasi test condotto prima dello screening).
13. Neonati o lattanti (ovvero, soggetti di età inferiore a 12 mesi) le cui madri biologiche presentavano una qualsiasi malattia sessualmente trasmessa entro 1 mese dal parto o anamnesi di herpes genitale.
14. Presenza di ostruzione del dotto naso-lacrimale alla Visita 1 (Giorno 1).
15. Presenza di qualsiasi condizione oftalmica significativa (per es. retinopatia del prematuro, cataratta congenita, glaucoma congenito) o altri disturbi congeniti con coinvolgimento oftalmico tali da alterare le variabili dello studio.
16. Nota pressione intraoculare (IOP) rispondente agli steroidi, nota anamnesi di glaucoma, sospetto di glaucoma o nota anamnesi di elevata IOP >21 mmHg.
17. Presenza di un qualsiasi difetto del nervo ottico clinicamente significativo.
18. Anamnesi di sindrome da erosione corneale recidivante, idiopatica o secondaria ad un precedente trauma corneale o sindrome dell’occhio secco; presenza di difetto dell’epitelio corneale o di qualsiasi opacità corneale significativa alla Visita 1.
19. Presenza di significativa condizione in fase attiva nel segmento posteriore tale da richiedere un trattamento invasivo (per es. trattamento intravitreale con inibitori del VEGF o corticosteroidi) e con probabilità di progressione durante il periodo di partecipazione allo studio.
L’elenco completo dei criteri di esclusione è reperibile nel protocollo.

E.5 End points

E.5.1

Primary end point(s)

Clinical resolution status (defined as absence of bulbar conjunctival injection and watery conjunctival discharge) in the study eye at Visit 3 (Day 6) between SHP640 and placebo

Stato di risoluzione clinica (definito come assenza di iniezione congiuntivale bulbare e secrezione congiuntivale acquosa) nell’occhio oggetto di studio alla Visita 3 (Giorno 6) tra SHP640 e placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 3 (Day 6)

Visita 3 (Giorno 6)

E.5.2

Secondary end point(s)

1. Clinical resolution and
2. Adenoviral eradication status (defined as negative cell cultureimmunofluorescence
assay [CC-IFA]) in the study eye.
Five hypotheses tests will be performed on the key secondary efficacy
endpoints at Visit 3 (Day 6) unless specified otherwise in following
order:
a. Comparison of proportion of subjects achieving clinical resolution
between SHP640 and PVP-I.
b. Comparison of proportion of subjects achieving adenoviral eradication
between PVP-I and Placebo at
Visit 2 (Day 3).
c. Comparison of proportion of subjects achieving adenoviral eradication
between SHP640 and Placebo.
d. Comparison of proportion of subjects achieving adenoviral eradication
between SHP640 and PVP-I.
e. Comparison of proportion of subjects achieving clinical resolution
between PVP-I and Placebo.
Secondary Efficacy Endpoints:
3. Absolute and change from baseline in adenovirus viral titer as
assessed by qPCR in the study eye
4. Adenoviral eradication status as assessed by CC-IFA in the study eye
5. The clinical resolution status of adenoviral conjunctivitis in the study
eye
6. The individual clinical signs score (bulbar conjunctival injection and
watery conjunctival discharge) and change from baseline in the study
eye
7. The global clinical score (as defined as the sum of bulbar conjunctival
injection and watery conjunctival discharge) and change from baseline
in the global clinical score in the study eye
8. Modified clinical resolution status, defined as a global clinical score of
0 or 1, in the study eye
9. Expanded clinical resolution status, defined as a global clinical score
of 0, 1, or 2 with neither injection nor discharge having a score of 2, in
the study eye
10. The status of cross-over infection (as assessed by CC-IFA) to a
subject's fellow eye for subjects with only 1 infected eye at baseline
11. Time to clinical resolution based upon assessments in the study eye
Safety Endpoints:
- Best Corrected Visual Acuity
- Slit Lamp Biomicroscopy
- Non-dilated/ Dilated Fundus Examination
- Urine Pregnancy Testing
- Adverse Events

1. Risoluzione clinica e
2. Stato di eradicazione dell¿adenovirus (definito come saggio di immunofluorescenza-coltura cellulare [CC-IFA] negativo) nell¿occhio oggetto di studio.
Cinque test di ipotesi sui principali endpoint di efficacia secondari alla Visita 3 (Giorno 6) verranno eseguiti, se non diversamente specificato, nel seguente ordine:
a. Confronto della percentuale di soggetti che raggiungono la risoluzione clinica tra SHP640 e PVP-I.
b. Confronto della percentuale di soggetti che raggiungono l¿eradicazione dell¿adenovirus tra PVP-I e placebo alla Visita 2 (Giorno 3).
c. Confronto della percentuale di soggetti che raggiungono l¿eradicazione dell¿adenovirus tra SHP640 e placebo.
d. Confronto della percentuale di soggetti che raggiungono l¿eradicazione dell¿adenovirus tra SHP640 e PVP-I.
e. Confronto della percentuale di soggetti che raggiungono la risoluzione clinica tra PVP-I e placebo.
Endpoint secondari di efficacia:
3. Cambiamento assoluto e rispetto al basale nel titolo virale dell¿adenovirus valutato mediante qPCR nell¿occhio oggetto di studio
4. Stato di eradicazione dell¿adenovirus valutato mediante CC-IFA nell¿occhio oggetto di studio
5. Stato di risoluzione clinica della congiuntivite da adenovirus nell¿occhio oggetto di studio
6. Punteggio relativo ai segni clinici individuali (iniezione congiuntivale bulbare e secrezione congiuntivale acquosa) e cambiamento dal basale nell¿occhio oggetto di studio
7. Punteggio clinico globale (definito come la somma di iniezione congiuntivale bulbare e secrezione congiuntivale acquosa) e cambiamento dal basale nel punteggio clinico globale nell¿occhio oggetto di studio
8. Stato di risoluzione clinica modificato, definito come punteggio clinico globale pari a 0 o 1, nell¿occhio oggetto di studio
9. Stato di risoluzione clinica esteso, definito come punteggio clinico globale pari a 0, 1 o 2, in cui n¿ l¿iniezione n¿ la secrezione presentano un punteggio pari a 2, nell¿occhio oggetto di studio
10. Stato di infezione cross-over (valutato mediante CC-IFA) nell¿altro occhio dei soggetti che presentavano 1 solo occhio infetto al basale
11. Tempo alla risoluzione clinica sulla base delle valutazioni dell¿occhio oggetto di studio
Endpoint di sicurezza:
- Migliore acuit¿ visiva corretta
- Biomicroscopia tramite lampada a fessura
- Esame del fondo oculare non dilatato/dilatato
- Test di gravidanza sulle urine
- Eventi avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

Key secondary endpoint:
1. Visit 3 (Day 6)2. Visits 2 (Day 3) and 3 (Day 6).
Secondary Efficacy Endpoints:
3. Visit 3 (Day 6) and 4 (Day 8)
4. Visits 4 (Day 8) and 5 (Day 12)
5. Visits 2 (Day 3), 4 (Day 8) and 5 (Day 12)
6. Visits 2 (Day 3), 3 (Day 6), 4 (Day 8) and 5 (Day 12)
7. Visits 2 (Day 3), 3 (Day 6), 4 (Day 8) and 5 (Day 12)
8. Visits 2 (Day 3), 3 (Day 6), 4 (Day 8) and 5 (Day 12)
9. Visits 2 (Day 3), 3 (Day 6), 4 (Day 8) and 5 (Day 12)
10.Visits 2 (Day 3), 3 (Day 6), 4 (Day 8) and 5 (Day 12)
11. Visits 2 (Day 3), 3 (Day 6), 4 (Day 8), and 5 (Day 12)
Safety Endpoints:
throughout study duration

1. Visita 3 (Giorno 6)
2. Visite 2 (Giorno 3) e 3 (Giorno 6).
Endpoint secondari di efficacia:
3. Visite 3 (Giorno 6) e 4 (Giorno 8)
4. Visite 4 (Giorno 8) e 5 (Giorno 12)
5. Visite 2 (Giorno 3), 4 (Giorno 8) e 5 (Giorno 12)
6. Visite 2 (Giorno 3), 3 (Giorno 6), 4 (Giorno 8) e 5 (Giorno 12)
7. Visite 2 (Giorno 3), 3 (Giorno 6), 4 (Giorno 8) e 5 (Giorno 12)
8. Visite 2 (Giorno 3), 3 (Giorno 6), 4 (Giorno 8) e 5 (Giorno 12)
9. Visite 2 (Giorno 3), 3 (Giorno 6), 4 (Giorno 8) e 5 (Giorno 12)
10.Visite 2 (Giorno 3), 3 (Giorno 6), 4 (Giorno 8) e 5 (Giorno 12)
11. Visite 2 (Giorno 3), 3 (Giorno 6), 4 (Giorno 8) e 5 (Giorno 12)
Endpoint di sicurezza:
per tutta la durata dello studio

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

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

PVP-I

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

Australia

Canada

Colombia

India

Israel

Peru

Philippines

South Africa

United States

Austria

Estonia

France

Germany

Hungary

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

Yes

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)

Yes

F.1.1.3.1