Clinical Trials Register

Summary
EudraCT Number:	2010-021188-34
Sponsor's Protocol Code Number:	LT2380-PIII-05/10
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-04-20
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

Portugal - INFARMED

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

A.3.1

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

Efficacy and safety assessment of an injectable solution containing the three active substances in the same vial (tropicamide, phenylephrine for mydriaticc effect and lidocaine for anesthesia) used for cataract surgery

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	Laboratoires Théa
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 Théa
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	Laboratoires Théa
B.5.2	Functional name of contact point	Clinical Trial Department
B.5.3	Address:
B.5.3.1	Street Address	12 Rue louis Blériot
B.5.3.2	Town/ city	Clermont-Ferrand
B.5.3.3	Post code	63017
B.5.3.4	Country	France
B.5.4	Telephone number	0033473981430
B.5.5	Fax number	0033473981424
B.5.6	E-mail	s.guyon@laboratoires-thea.fr

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	Mydrane
D.3.2	Product code	T2380
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ophthalmic use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	73-78-9
D.3.9.3	Other descriptive name	LIDOCAINE HYDROCHLORIDED
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
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.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,31
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1508-75-4
D.3.9.3	Other descriptive name	TROPICAMIDE
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,02
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	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	MYDRIATICUM
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATOIRES THEA
D.2.1.2	Country which granted the Marketing Authorisation	France
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	TROPICAMIDE
D.3.4	Pharmaceutical form	Eye drops
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.3.9.1	CAS number	1508-75-4
D.3.9.3	Other descriptive name	TROPICAMIDE
D.3.9.4	EV Substance Code	SUB11342MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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.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	Yes
D.2.1.1.1	Trade name	NeosynephrineFaure
D.2.1.1.2	Name of the Marketing Authorisation holder	EUROPHTA
D.2.1.2	Country which granted the Marketing Authorisation	France
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	PHENYLEPHRINE
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Eye drops
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	Phenylepherine hydrochloride
D.3.9.1	CAS number	61-76-7
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
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: 4
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	TETRACAINE
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS
D.2.1.2	Country which granted the Marketing Authorisation	France
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	TETRACAINE
D.3.4	Pharmaceutical form	Eye drops
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	TETRACAINE HYDROCHLORIDE
D.3.9.1	CAS number	136-47-0
D.3.9.4	EV Substance Code	SUB04754MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The aim of this clinical study will be to develop a combination of active substances enabling to obtain at the same time a mydriasis and an anaesthesia during cataract surgery

E.1.1.1

Medical condition in easily understood language

Patient with cataract

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	PT
E.1.2	Classification code	10011719
E.1.2	Term	Cycloplegia
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10002325
E.1.2	Term	Anesthesia local
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10028521
E.1.2	Term	Mydriasis
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

Primary efficacy variableThe primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment. A responder is defined as a patient for whom the capsulorhexis is performed without use of any additive mydriatic treatment.Additive treatments are for both groups any supplementary drug with a mydriatic action other than planned by the protocol, and/or the use of medical device for opening the pupil, between the first instillation of study product and the capsulorhexis.Co-primary efficacy variableThe co-primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment and the measurement of pupil size just before capsulorhexis (T3). A responder is defined as a patient for whom the capsulorhexis is performed without use of any additive mydriatic treatment and for whom the pupil size at T3 is greater than or equal to 5.5 mm.

E.2.2

Secondary objectives of the trial

Secondary efficacy variables
-Pupil size measured at the time T4.
-Pupil size measured at the times T1, T2, T3 and T5.
-Assessment of patient's discomfort at T1 to T5.
-Time necessary for obtaining sufficient mydriasis :
-For T2380 group : Delay between the first injection and T3-For reference group : Delay between the first instillation of mydriatic and T3
-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 (mydriatic for reference group, tetracaine for T2380 group) and the first incision.
-Delay between T3 and cefuroxime injection
-Total surgical time (first incision to cefuroxime injection)
-Assessment of the surgeon statisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation).

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
-Pupil diameter ≥ 7 mm at selection visit after dilatation

E.4

Principal exclusion 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

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment. The co-primary efficacy variable is response based on the realisation of the capsulorhexis without use of any additive mydriatic treatment and a pupil size just before capsulorhexis (T3) greater than or equal to 5.5 mm. Patients for whom the data are not available to determine responseare considered to be non-responders.The statistical hypothesis tested is the non-inferiority of T2380 to the reference treatment. A two-sided 95% confidence interval on the difference in responder rates between the T2380 group and the reference treatment (T2380 minus reference treatment) will be derived to assess the hypothesis.T2380 will be declared to be non-inferior to the reference treatment if the lower bound of the 95% confidence interval on the difference in rates between the two treatment groups is greater than or equal to -7.5%.

E.5.1.1

Timepoint(s) of evaluation of this end point

Evaluation will be realised the day of surgery :
The endpoint of primary efficacy variable will be Capsulorhexis
The endpoint of co-primary efficacy variable will be Just before Capsulorhexis

E.5.2

Secondary end point(s)

Pupil size measured
Assessment of patient's discomfort
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 (mydriatic for reference group, tetracaine for T2380 group) and the first incision.
Delay between T3 and cefuroxime injection
Total surgical time (first incision to cefuroxime injection)
Assessment of the surgeon statisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation).

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary efficacy variable will be realsied the day of surgery on T1, T2, T3, T4 AND T5.

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

Yes

E.6.6

Pharmacokinetic

Yes

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

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

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

The end of the trial will be the last visit of the last subject undergoing the trial

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