Clinical Trials Register

Summary
EudraCT Number:	2010-021188-34
Sponsor's Protocol Code Number:	LT2380-PIII-05/10
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:	2012-02-27
Trial 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-021188-34

A.3

Full title of the trial

Efficacy and safety assessment of intracameral T2380 (Fixed combination of lidocaine, phenylephrine and tropicamide) for mydriasis and anaesthesia in phacoemulsification cataract surgery

Valutazione della efficacia midiatrica e anestetica e della tolleranza di una soluzione iniettabile per via intracamerulare di T2380 (associazione fissa di lidocaina, fenilefrina e tropicamide) nella chirurgia della cataratta per facoemulsificazione.

A.3.1

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

Evaluation of efficacy, safety and anaesthetic effect of esolution administered during cataract surgery.

Valutazione dell'effetto di dilatazione sulla pupilla, dell'efficacia anestetica e della tolleranza di una soluzione somministrata nel bulbo oculare durante l'intervento chirurgico di cataratta per facoemulsificazione.

A.4.1

Sponsor's protocol code number

LT2380-PIII-05/10

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	LABORATORIES THEA
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	LABORATOIRES THEA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	PHIDEA MARVIN S.R.L.
B.5.2	Functional name of contact point	Cristina Lumini - Project Manager
B.5.3	Address:
B.5.3.1	Street Address	Via C. Colombo, 1
B.5.3.2	Town/ city	Corsico
B.5.3.3	Post code	20094
B.5.3.4	Country	Italy
B.5.4	Telephone number	+ 390245053519
B.5.5	Fax number	+ 390245053505
B.5.6	E-mail	cristina.lumini@phideamarvin.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	T2380
D.3.2	Product code	T2380
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	LIDOCAINE HYDROCHLORIDE
D.3.9.1	CAS number	73-78-9
D.3.9.2	Current sponsor code	T2380
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB02921MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PHENYLEPHRINE HYDROCHLORIDE
D.3.9.1	CAS number	61-76-7
D.3.9.2	Current sponsor code	T2380
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB03777MIG
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	.31
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TROPICAMIDE
D.3.9.1	CAS number	1508-75-4
D.3.9.2	Current sponsor code	T2380
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB11342MIG
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	.02
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	Yes
D.3.11.13.1	Other medicinal product type	soluzione locale con effetto anestetico e midriatrico

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

subjects with cataract

Pazienti affetti da cataratta

E.1.1.1

Medical condition in easily understood language

subjects affected by cataract phatology

soggetti affetti da cataratta

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 primary aim of this study is to evaluate mydriasis of T2380 versus topical reference treatments during cataract surgery.

L’obiettivo principale di questo studio sarà valutare la dilatazione pupillare (midriasi) ottenuta con il T2380, confrontandola a quella ottenuta con trattamenti topici nel gruppo di controllo durante l’intervento della cataratta.

E.2.2

Secondary objectives of the trial

Pupil size measured at the time T4;Pupil size measured at the times;Assessment of patient’s discomfort at T1 to T5;Time necessary for obtaining sufficient mydriasis; Questioning about the number of supplementary drops or injection necessary to maintain mydriasis;Questioning about the number of supplementary drops or injection necessary to maintain anaesthesia; Delay between the first instillation and the first incision; Delay between T3 and cefuroxime injection; Total surgical time;Assessment of the surgeon statisfaction of each stage

Misurazione della dimensione della pupilla nel tempo T4;Misurazione della dimensione della pupilla nel tempo;Valutazione del disagio del paziente da T1 a T5;Tempo necessario per l’ottenimento di una midriasi sufficiente;Numero di gocce o volume di iniezioni aggiuntive necessarie per mantenere la midriasi;Numero di gocce o volume di iniezioni aggiuntive necessarie per mantenere l’anestesia;Intervallo tra la prima instillazione e la prima incisione;Intervallo tra T3 e l’iniezione di Cefurossima;Durata totale dell’intervento chirurgico;Valutazione della soddisfazione del chirurgo durante le fasi seguenti: 2a incisione, capsuloressi, facoemulsificazione, aspirazione della corteccia, inserimento dell’impianto.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Signed and dated informed consent;Male or female aged from 40 to 88 years old; Scheduled to undergo unilateral cataract surgery (Under topical anesthesia and using clear corneal self sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector); Pupil diameter ≥ 7 mm at selection visit [after the following dilatation protocol: 1 tropicamide 0.5% + 1 drop phenylephrine 10%; with a maximum of 3 combined instillations with interval of 10 mn, i.e. T 0mn, + T 10mn and + T 20mn if necessary]

Consenso informato datato e firmato;Uomo o donna, di età compresa tra 40 e 88 anni;Chirurgia unilaterale della cataratta programmata (In anestesia locale, incisione in cornea chiara autosigillante-facoemulsificazione-con lente intraoculare morbida e iniettore);Diametro della pupilla dilatata ≥ 7 mm durante la visita di selezione [In base alla procedura di dilatazione seguente: 1 goccia di tropicamide 0,5% + 1 goccia di fenilefrina 10%; procedura ripetuta 3 volte al massimo con un intervallo di 10 min].

E.4

Principal exclusion criteria

Ophthalmic non-inclusion criteria  Surgical conditions in the eye to be operated: - Combined surgery - Previous intraocular surgery  Non-surgical conditions in the eye to be operated: - Iatrogenic or traumatic or congenital cataract. - Pupillary abnormalities (irregular,..) - Very dark iris - Iris synechiae - Eye movement disorder (Nystagmus,..) - Dacryocystitis and all others pathologies of tears drainage system - History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis,…) - Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) - History of ocular traumatism, infection or inflammation within the last 3 months - Pseudoexfoliation, exfoliative syndrome,  Ophthalmic conditions in the contra lateral eye: - Best corrected visual acuity < 1/10 - Patient already included in the study for phakoexeresis - History of ophthalmic surgical complication (cystoid macular oedema,..)  Presence of glaucoma and/or ocular hypertension history in either eye Systemic/non ophthalmic non-inclusion criteria None of the following criteria  General history: - Diabetes not controlled - Insulin-dependent diabetes - Surdity - Excessive anxiety - Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled arterial hypertension etc...) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study  Allergic history: - Known hypersensitivity to one of the components of the study medications or to test products - Allergic rhinitis Specific non-inclusion criteria for women - Pregnancy, lactation - Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR - Women not hysterectomised, menopaused or surgically sterilized Non-inclusion criteria related to general conditions - Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent - Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) - Participation in another clinical study - Already included once in this study - Ward of court - Patient not covered by the Social Security scheme (For France)

 Condizioni chirurgiche nell’occhio da operare: - Chirurgia combinata; - Antecedente di chirurgia intraoculare.  Condizioni non-chirurgiche nell’occhio da operare: - Cataratta iatrogena, traumatica o congenita; - Anomalia della pupilla (irregolarità…); - Iride molto scura; - Sinechia dell’iride; - Movimento involontario dell’occhio (Nistagmo…); - Dacriocistite e altra patologia legata al sistema di drenaggio delle lacrime; - Antecedenti di patologia infiammatoria oculare (irite, uveite, cheratite erpetica); - Patologia corneale, epiteliale, stromale o endoteliale, residua o evolutiva (incluse ulcera corneale e cheratiti puntate superficiali); - Antecedente di trauma oculare, infezione o infiammazione negli ultimi 3 mesi; - Sindrome da esfoliazione o pseudo esfoliazione.  Condizioni oftalmologiche nell’occhio controlaterale: - Acuità visiva corretta < 1/10; - Paziente già incluso nello studio per una faco-exeresi; - Antecedente di complicanza chirurgica (specificatamente edema maculare cistoide,...).  Glaucoma e/o antecedente di ipertensione oculare in uno dei due occhi. Criteri di esclusione di ordine sistemico (non oftalmologico):  Antecedenti di ordine generale: - Diabete non controllato; - Diabete insulino-dipendente; - Sordità; - Ansia eccessiva; - Qualsiasi antecedente medico o chirurgico, disordine o malattia quale una malattia metabolica acuta o cronica grave: epatica, endocrina, neoplasica, ematologica, malattia psichiatrica grave, patologia cardiovascolare non controllata… (quale ad esempio: angor instabile, ipertensione non controllata, ecc) e/o qualsiasi fattore aggravante o anomalia strutturale, giudicata dal ricercatore incompatibile con lo studio.  Antecedente di allergia: - Ipersensibilità nota a uno dei componenti dei prodotti dello studio o prodotti utilizzati nel presente studio; - Rinite allergica. Criteri di esclusione specifici per le donne: - Gravidanza o allattamento; - Donna in età fertile che non utilizzi metodi contraccettivi sicuri (contraccettivi orali, spirale o contraccezione mediante impianto sottocutaneo) oppure che non sia stata sottoposta a sterilizzazione chirurgica o che non sia in menopausa. Criteri di esclusione legati alle condizioni generali: - Paziente incapace di comprendere le istruzioni dello studio e pertanto di fornire il proprio consenso informato; - Paziente non osservante (ad esempio non disposto a presentarsi alle visite di controllo, stile di vita che interferisce con l’osservanza); - Paziente che partecipa ad altro studio clinico; - Paziente già incluso nel presente studio; - Maggiore sotto tutela; - Soggetto non iscritto al regime di previdenza sociale (per la Francia).

E.5 End points

E.5.1

Primary end point(s)

Midriasys evaluation activities

Valutazione dell'attività midriatrica

E.5.1.1

Timepoint(s) of evaluation of this end point

Maximun 1 month after surgery

massimo 1 mese dopo l'intervento chirurgico

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

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)

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

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

LPLV december 2012

LPLV dicembre 2012

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

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

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

492

F.4.2.2

In the whole clinical trial

492

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)

no patient follow up after the end of the study is planned

Non è previsto nessun trattamento e/o assistenza dopo il termine dello studio

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

2011-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-25

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials