Clinical Trials Register

Summary
EudraCT Number:	2012-001556-19
Sponsor's Protocol Code Number:	COL_SCU_2011
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-05-29
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2012-001556-19

A.3

Full title of the trial

A Prospective, Randomized, Doubled-masked, Single Center, Clinical Comparison of Autologous Serum, Heterologous Serum and Umbilical Cord Serum Eye Drops in the Management of Dry Eye Syndrome

ENSAYO CLÍNICO DOBLE CIEGO Y ALEATORIZADO, UNICÉNTRICO, COMPARATIVO ENTRE COLIRIO DE SUERO AUTÓLOGO, SUERO HETERÓLOGO Y SUERO DE SANGRE DE CORDÓN UMBILICAL EN EL TRATAMIENTO DE PACIENTES CON OJO SECO

A.3.1

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

Dry eye treatment

Tratamiento ojo seco

A.3.2

Name or abbreviated title of the trial where available

COL_SCU_2011

A.4.1

Sponsor's protocol code number

COL_SCU_2011

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	FUNDACION IMABIS
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, Asuntos Sociales e Igualdad
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	HOSPITAL RU CARLOS HAYA
B.5.2	Functional name of contact point	INVESTIGACION
B.5.3	Address:
B.5.3.1	Street Address	Avda Carlos Haya s/n
B.5.3.2	Town/ city	Malaga
B.5.3.3	Post code	29010
B.5.3.4	Country	Spain
B.5.4	Telephone number	34951291977
B.5.5	Fax number	34951440263
B.5.6	E-mail	gloria.luque.exts@juntadeandalucia.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	Colirio de sangre de cordón umbilical
D.3.4	Pharmaceutical form	Eye drops
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	Umbilical Cord Serum Eye Drops
D.3.9.2	Current sponsor code	COL_SCU
D.3.9.3	Other descriptive name	Suero rico en sustancias lubricantes y nutrientes procedentes de cordón umbilical
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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.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	Colirio de suero autólogo
D.3.4	Pharmaceutical form	Eye drops
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Suero autólogo con sustancias lubricantes y nutrientes
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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.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	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	Colirio suero heterólogo
D.3.4	Pharmaceutical form	Eye drops
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Suero heterólogo con sustancias lubricantes y nutrientes
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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

Ocular surface disturbances.

Alteración de la superficie corneal

E.1.1.1

Medical condition in easily understood language

Dry eye

Ojo seco

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

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 valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord therapy in patients with severe dry eye syndrome.

To accomplish clinical comparison of the effects between the three therapies.

Evaluar la eficacia en el tratamiento de los signos y síntomas del ojo seco de los tres tipos de colirios (Suero autólogo, Suero heterólogo y de sangre de cordón umbilical) y compararlos entre sí.

E.2.2

Secondary objectives of the trial

PRIMARY OBJECTIVES:
1) To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord serum therapy in patients with severe dry eye syndrome.

2) To accomplish clinical comparison of the effects between the three therapies.

SECONDARY OBJECTIVES:
To determine by ELISA in autologous, heterologous and umbilical cord:

1) Growth factors: EGF, TGF-? and PDGF.
2) Neurotrophic factors: IGF -1, P suBstance, ?2 microglobulin and fibronectin.
3) Essentials tear components like A vitamina, IgG, lisozima and complement factors.

Factor Crecimiento Epitelial, fibroblastos, plaquetas,VitaminaA.Proteínas:albúmina,macroglobulina,fibronectina. Factores neuronales: sustancia P, Factor de Crecimiento tipo Insulina 1.IgG, lisozima y factores del complemento. Valoración película lagrimal y cambios superficie ocular tras 3 terapias mediante pruebas oftalmológicas: Test de Shirmer tipo I Tinción con fluoresceína y tiempo de ruptura de la película lagrimal, realización citología de impresión conjuntival y
fotografía polo anterior para valorar mejoría o no de lesiones corneales. Análisis anatomopatológico de muestras conjuntivales. Despistaje de agentes transmisibles en pacientes y en sueros heterólogos mediante ELISA. Evaluar posible sensibilización de pacientes de suero heterólogo. Comprobar los efectos del tratamiento con suero autólogo, heterólogo y de cordón umbilical. Estudio de síntomas subjetivos mediante cuestionario de evaluación antes y después del tratamiento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Dry eye symptoms (red eyes, lid inflammation, discharge, dry eye, sandy and foreign body sensations, burning, itching, discomfort, pricking, tearing and photophobia) for more than three months.
- BUT < 5 seconds or
- Schirmer Test (tipe I) < 5 mm.
- Patients over 18 years old with severe dry eye of all etiologies.
- previous signment of informed consent.

1. Síntomas de ojo seco por más de tres meses.
2. Test de Schirmertipo I < 5 mm.
3. Tiempo de rotura lagrimal <a 5 segundos.
Los pacientes deben presentar en el momento de ser incluidos en el ensayo clínico, 2 de los 3 síntomas/signos mencionados.

Se incluyen en el estudio los pacientes con ojo seco de las siguientes etiologías:
1. Síndrome de ojo seco no asociado a colagenopatía
? Idiopático
? Secundario: DGM, Mucodeficiente, Ojo seco evaporativo (DLA), Rosácea, Síndrome del párpado fláccido, Queratoconjuntivitis límbica superior, Radioterapia, queratopatía bullosa, enfermedad de Garves-Basedow.
2. Síndrome de ojo seco secundario a Síndrome de Sjögren, primario o secundario: Artritis reumatoide, Lupus eritematoso sistémico, Esclerodermia, Dermatomiositis, Enfermedad mixta del tejido conectivo, Tiroiditis de Hashimoto, Cirrosis biliar primaria, Hepatitis crónica autoinmune.
3. Otros: Úlcera neurotrópica, Defecto epitelial persistente, Queratopatía por exposición, Queratopatía Cálcica, Distrofias Corneales, Úlceras marginales secundarias a vasculitis sistémicas, úlcera de Mooren, úlcera de Terrien, Enfermedad Injerto contra huésped crónico y Síndrome de InsuficienciaLimbar: Síndrome de Stevens-Johnson, Penfigoide y Causticación corneal.
- Firma previa del consentimiento informado.

E.4

Principal exclusion criteria

1) Eye-infection or inflammation not related to the dry eye.
2) Contact lens users.
3) Ocular allergy in the past three months.
4) Eyelid and eyelashes malpositions.
5) Pregnant women
6) Positive infectious diseases (haepatitis B and C, HIV and syphilis.
7) Patients with problems related to blood extraction.
8) Patients that have in a clinical trail 30 days prior to the inclusion, in which there has been topical therapy.
9) Patients with chronical therapy with topical corticosteroids.

1) Menores de 18 años.
2) Mujeres embarazadas.
3) Usuarios de lentes de contacto.
4) Historia de alergia ocular en los últimos 3 meses.
5) Alteraciones anatómicas de párpado y pestañas
6) Enfermedades infecto-contagiosas transmisibles (Hepatitis By C, VIH y sífilis).
7) Pacientes con dificultades para la extracción sanguínea.
8) Pacientes que hayan participado en los 30 días previso en otro ensayo clínico en el que se aplique una terapia tópica.
9) Pacientes en tratamiento con corticoides tópicos crónicos.

E.5 End points

E.5.1

Primary end point(s)

To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord serum therapy in patients with severe dry eye syndrome.

To accomplish clinical comparison of the effects between the three therapies.

Evaluar la eficacia en el tratamiento de los signos y síntomas del ojo seco de los tres tipos de sueros (Suero autólogo, Suero heterólogo y suero de sangre de cordón umbilical) y compararlos entre sí.

E.5.1.1

Timepoint(s) of evaluation of this end point

44 and 74 days

44 y 74 días

E.5.2

Secondary end point(s)

1) To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord serum therapy in patients with severe dry eye syndrome.

2) To accomplish clinical comparison of the effects between the three therapies.

SECONDARY OBJECTIVES:
To determine by ELISA in autologous, heterologous and umbilical cord:

1) Growth factors: EGF, TGF-? and PDGF.
2) Neurotrophic factors: IGF -1, P suBstance, ?2 microglobulin and fibronectin.
3) Essentials tear components like A vitamina, IgG, lisozima and complement factors.

E.5.2.1

Timepoint(s) of evaluation of this end point

44 and 74 days

44 y 74 días

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

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

Yes

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

In Spain the trial will be done drom 2012 to the end of 2014

El estudio se realizará desde el 2012 a finales de 2014

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:

110

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

123

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)

Expected treatment

Mismo tratamiento esperado

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

2012-11-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-01

P. End of Trial
P.	End of Trial Status	Ongoing

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