Clinical Trials Register

Summary
EudraCT Number:	2011-006287-50
Sponsor's Protocol Code Number:	EMAOS
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-01-11
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

Spain - AEMPS

A.2

EudraCT number

2011-006287-50

A.3

Full title of the trial

Phase III comparative clinical trial to evaluate the efficacy of amniotic membrane extract for the treatment of severe dry eye disease, in comparison with autologous serum eyedrops.

Ensayo Clínico fase III del Extracto de membrana amniótica como tratamiento sintomático del ojo seco severo en comparación con el tratamiento mdiante colirio de suero autólogo

A.3.1

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

Comparative study to evaluate two different treatments for severe dry eye disease. Amniotic membrane extract versus autologous serum eyedrops.

Ensayo Clínico del Extracto de membrana amniótica como tratamiento del ojo seco severo en comparación con el tratamiento mdiante colirio de suero autólogo

A.4.1

Sponsor's protocol code number

EMAOS

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	Clínica Universidad de Navarra/Universidad de Navarra
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ministerio de Sanidad y Política Social
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clínica Universidad de Navarra
B.5.2	Functional name of contact point	UCICEC
B.5.3	Address:
B.5.3.1	Street Address	Avda. Pío XII, 36
B.5.3.2	Town/ city	Pamplona
B.5.3.3	Post code	31008
B.5.3.4	Country	Spain
B.5.4	Telephone number	34948255 4002725
B.5.5	Fax number	34948296 667
B.5.6	E-mail	ucicec@unav.es

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	Extracto de membrana amniótica
D.3.2	Product code	Extracto de membrana amniótica
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	Ophthalmic use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	membrana amniotica
D.3.9.3	Other descriptive name	membrana amniotica
D.3.10	Strength
D.3.10.1	Concentration unit	Other
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	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	Suero autologo (Plasma Transfusional-No es PRP)
D.3.2	Product code	Suero autologo (Plasma Transfusional-No es PRP)
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	Ophthalmic use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Suero autologo (Plasma Transfusional-No es PRP)
D.3.9.3	Other descriptive name	Suero autologo (Plasma Transfusional-No es PRP)
D.3.10	Strength
D.3.10.1	Concentration unit	Other
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

Severe Dry Eye Disease

Ojo seco severo

E.1.1.1

Medical condition in easily understood language

Severe Dry Eye Disease

Ojo seco severo

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	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10013778
E.1.2	Term	Dry eyes
E.1.2	System Organ Class	100000004853

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 establish the efficacy of topical amniotic membrane extract to treat symptoms of severe dry eye disease.

Determinar la eficacia del tratamiento sintomático del ojo seco severo mediante extracto de membrana amniótica administrado por vía tópica

E.2.2

Secondary objectives of the trial

Determine product tolerance in the eye.
Validate changes in tear osmolarimetry.
Validate reduction of inflammatory response at the ocular surface.
Compare results with autologous serum eyedrops.

Determinar la tolerancia del producto.
Valorar el cambio de osmolaridad lagrimal.
Valorar la respuesta inhibidora de la inflamación en la superficie ocular.
Comparar los resultados con el colirio de suero autólogo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must be able to provide informed consent and express their desire tu fulfil every requirement during the study.
Patients between 18 and 65 years old.
Patients diagnosed with severe dry eye disease according to DEWS classification.

-Capacidad para otorgar consentimiento informado y expresar su deseo de cumplir todos los requisitos del protocolo durante el periodo de estudio.
-El/la paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
-El paciente deberá tener entre 18 y 65 años de edad.
-Diagnóstico clínico de ojo seco severo o muy severo de la clasificación de DEWS.

E.4

Principal exclusion criteria

Systemic disease that can compromise patients participation in the study, according to investigator (hepatic failure, etc?)
Previous ocular surgeries that can alter or modify the ocular surface (refractive surgery, palpebral surgery, corneal surgery)
Patient is under systemic medication that can affect tear production.
Contact lens wear.
Pregnancy.
Smoking.
Concomitant palpebral pathology (lagoftalmos, exoftalmos, ectropion, etc?)

-Infecciones o enfermedades graves o insuficiencia hepática, renal o medular que desaconsejen la participación del paciente en el estudio, según el criterio del investigador.
-Mujeres embarazadas o en período de lactancia.
-Serología positiva para VIH, Hepatitis B y C.
-Tratamiento de otros medicamentos por vía tópica que utilicen conservantes: glaucoma, blefaritis, etc.
-Cirugías oculares previas que afecten la superficie ocular (cirugía refractiva, cirugía palpebral, cirugía corneal).
-Uso de medicación sistémica que puede producir alteraciones en la lágrima.
-Utilización de lentes de contacto.
-Patología palpebral asociada (lagoftalmos, exoftalmos, ectropión, etc.)
-Pacientes con trabajo diario al aire libre o que utilicen productos irritantes oculares (agrícola, ganadería, construcción, forestación, etc...).
-Pacientes fumadores

E.5 End points

E.5.1

Primary end point(s)

1. Determine tear volume and clearance by Schirmer Test type I and FCT (Fluorescein Clearance test) according to Tseng technique (10, 20 and 30 minutes).
2. Determine tear stability by TBUT (tear break up time).
3. Ocular surface Impression cytology analysis:
3.1. goblet cells quantity.
3.2. HLA-DR expression.
3.3. MUC1 expression.

1. Determinación del volumen y aclaramiento lagrimal mediante test Schirmer y del FCT (Fluorescein Clearance Test) según técnica descrita por Tseng (10, 20 y 30 minutos).
2. Determinación de estabilidad lagrimal mediante Tiempo de Rotura Lagrimal.

3. Análisis mediante citología de impresión de la superficie ocular:
3.1. Número de células goblet.
3.2. Expresión de HLA-DR.
3.3. Expresión de MUC1

E.5.1.1

Timepoint(s) of evaluation of this end point

1,3 and 6 months

1,3 y 6 meses

E.5.2

Secondary end point(s)

1. Tear osmolarity.
2. Symptoms subjective validation by OSDI questionnaire.
3. Product tolerance subjective validation by EVA (visual analogic scale).

1. Osmolaridad lagrimal.
2. Valoración subjetiva de sintomatología de los pacientes mediante cuestionario de OSDI (OSDI Score).
3. Valoración subjetiva de la tolerancia del producto (escala visual analógica (EVA))

E.5.2.1

Timepoint(s) of evaluation of this end point

1,3 and 6 months

1,3 y 6 meses

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

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

Yes

E.8.1.7.1

Other trial design description

con evaluador ciego

blinded assessor

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

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

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)

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.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)

Standard procedure of care.

Tratamiento habitual para la patología

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

2015-04-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-17

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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