Clinical Trials Register

Summary
EudraCT Number:	2014-002319-41
Sponsor's Protocol Code Number:	HULP-VIR-2014-01
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:	2014-08-11
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

2014-002319-41

A.3

Full title of the trial

Clinical and virologic assesment of two therapeutic options: antiviral Ganciclovir 0.15% ophthalmic gel and physiologic saline solution 0.9% used in patients with acute adenoviral conjuntivitis.

VALORACIÓN DE LA RESPUESTA CLÍNICA Y VIROLÓGICA DE DOS ALTERNATIVAS TERAPÉUTICAS: ANTIVIRAL GANCICLOVIR GEL OFTÁLMICO 0,15% Y SUERO FISIOLÓGICO 0.9% EN PACIENTES CON CONJUNTIVITIS AGUDA ADENOVÍRICA.

A.3.1

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

Study of the comparative efficacy of two different treatments used in acute conjunctivitis by adenovirus: Ganciclovir 0.15% and saline solution 0.9%.

Valoración de la eficacia de dos tratamientos usados en conjuntivitis aguda por adenovirus: ganciclovir 0.15% y suero salino 0.9%.

A.4.1

Sponsor's protocol code number

HULP-VIR-2014-01

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	Ana Boto de los Bueis
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	Laboratorios Thea
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	Ana Boto de los Bueis
B.5.2	Functional name of contact point	Almudena del Hierro
B.5.3	Address:
B.5.3.1	Street Address	Paseo de la Castellana, 261
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28046
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034917277259
B.5.5	Fax number	0034934766811
B.5.6	E-mail	adelhierro24@gmail.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	Yes
D.2.1.1.1	Trade name	VIRGAN Gel oftálmico 1,5 mg/g
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoires Théa
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	VIRGAN Gel oftálmico 1,5 mg/g
D.3.4	Pharmaceutical form	Eye gel
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	2-amino-9-{[(1,3-dihydroxypropan-2-yl)oxy]methyl}-6,9-dihydro-3H-purin-6-one
D.3.9.1	CAS number	82410-32-0
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.5
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: 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	Hidrathea
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios Thea
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Hidrathea
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	Sodium chloride
D.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	Salt
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	9
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

Acute adenoviral conjunctivitis

Conjuntivitis aguda por adenovirus

E.1.1.1

Medical condition in easily understood language

Conjunctiva infection by adenovirus

Infección de la conjuntiva causada por adenovirus

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	18.0
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

To evaluate the viral and clinical response reached by an antiviral drug (ganciclovir 0.15%) and an ocular hydrating agent (0.9%) in patients with acute adenoviral conjunctivitis.

Determinar la respuesta virológica y clínica de un antiviral (ganciclovir 0.15%),y un agente hidratante (suero fisiológico 0.9%) en pacientes con síntomas agudos de conjuntivitis adenovírica (CAd).

E.2.2

Secondary objectives of the trial

-To know the incidence of acute adenoviral conjunctivitis in the investigational site
-To identify the most frequent adenovitral strains foun in the investigational site
-To evaluate the most suggesting symptoms associated to adenoviral conjunctivitis
-To evaluate the safety of the two treatments used during the trial

-Conocer la incidencia de CAd en los consultantes de nuestro hospital
-Tipificar las cepas adenovirales más prevalentes en los consultantes de nuestro hospital.
-Determinar los síntomas más sugestivos de conjuntivitis adenovírica.
-Evaluar la seguridad de los dos tratamientos utilizados durante el estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female aged ? 18 years old
2. Patients with uni or bilateral folicular conjunctivitis (7 days) and at least one of the following signs:
-Tarsal micro-haemorrhages
-Preauricular lynphadenopathy
-Previous or ongoing upper respiratory disease
-Known history of recent contact with viral conjunctivitis
-Iatrogenic exposure to viral infection (ophtlamologist, health-care center) during last 7 days
3. Patients understanding complexity of the study and agree with signed informed consent.

1. Pacientes, hombres o mujeres, de ? 18 años de edad
2. Paciente con diagnóstico de conjuntivitis uni o bilateral folicular de inicio agudo (7 días) y que cumpla al menos uno de los 5 siguientes signos:
- Microhemorragias tarsales
- Linfadenopatía preauricular
- Enfermedad tracto respiratorio superior anterior o concomitante.
- Historia de contacto reciente con afecto de conjuntivitis vírica.
- Exposición iatrogénica (contacto con oftalmólogo o centro hospitalario en la última semana)
3. Pacientes habiendo entendido las condiciones y particularidades del estudio y que haya dado su aprobación a participar mediante la firma del consentimiento informado

E.4

Principal exclusion criteria

1. Patients having viral conjunctivitis sympomathology longer tan 7 days.
2 Patients showing fluorescein-stained cornea: geographic or dendritic distribution.
3. Patients with corneal subepithelial infiltrates.
4. Patients with severe dry eye.
5. Intraocular inflammation (uveítis).
6. Patients under systemic corticoid treatment because of systemic pathology having no relation with any exclusión criteria.
7.Known history of atopy
8. Known history of allergy to medicinal study treatment active ingredients or any other ingredient.

The protocol also defines other exclusion criteria such as systemic/non ophthalmic exclusion criteria, specific exclusion criteria for women, exclusion criteria related to general and ethic conditions and exclusion criteria related to previous and concomitant medications/ non-product therapies.

1. Pacientes presentando una conjuntivitis con una duración de los síntomas > 7 días.
2. Pacientes presentando tinción corneal dendrítica o geográfica.
3. Paciente mostrando infiltrados corneales subepiteliales.
4. Paciente con enfermedad grave de superficie ocular.
5. Inflamación intraocular (uveítis)
6. Paciente en tratamiento con corticoide tópico por patología concomitante que no constituye criterio de exclusión
7. Paciente con una historia previa de atopia
8. Paciente con historia de alergia a alguno de los componentes o principios activos utilizados como tratamientos en el estudio.

El protocolo también define como otros criterios de exclusión aquéllos relacionados con la presencia o historia de patologías sistémicas determinadas, aquéllos relacionados específicamente a mujeres, los de ámbito o aplicación ética o general, los relacionados con tratamientos previos o concomitantes.

E.5 End points

E.5.1

Primary end point(s)

1. Analysis of viral load from conjunctival samples of the patients.
2. Analysis of the symptomatology described by the patient in agreement with listed symptoms specified in the protocol (foreing body sensation, photophobia, tearing, burning/itching).
3. Analysis of clinical signs showed during ophthalmic examination (edema, injection, secretion, corneal staining, pseudomembranes).

1. Evaluación de la carga viral en las muestras de hisopados obtenidos de los pacientes.
2. Evaluación de la sintomatología referida por los pacientes de acuerdo con los síntomas especificados en este protocolo (sensación de cuerpo extraño, fotofobia, lagrimeo, picor).
3. Evaluación de los signos clínicos observados durante la exploración oftalmológica (edema, inyección, secreción, tinción corneal, pseudomembranas).

E.5.1.1

Timepoint(s) of evaluation of this end point

1 D0 (basal value) and D2, D4 and D7
2. D0 (basal value) and D4, D7, D21 and D90
3. D0 (basal value) and D2, D4, and D7 (edema, injection, secretion, corneal staining, pseudomembranes).
D0 (basal value) and D21 and D90 (edema and pseudomembranes)

1. D0 (tomado como valor basal) y D2, D4 y D7
2. D0 (tomado como valor basal) y D4, D7, D21, D90
3. D0 (tomado como valor basal) y D2, D4 y D7 (edema, inyección, secreción, tinción corneal, pseudomembranas)
D0 (tomado como valor basal) y D21 y D90 (edema, pseudomembranas)

E.5.2

Secondary end point(s)

-Analysis of visual acuity score by best corrected visual acuity parameter (BCVA)
-Analysis and identification of local/systemic, simple/serious adverse reactions.

-Evaluar el parámetro de agudeza visual mediante la mejor agudeza visual corregida (MAVC).
-Evaluar e identificar las reacciones adversas locales y sistémicas, simples y graves.

E.5.2.1

Timepoint(s) of evaluation of this end point

-D0 (basal value) and D21, D90.
-During the whole study time.

-D0 (tomado como valor basal) y D21, D90.
-Se determinará a lo largo de todo el periodo del estudio.

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

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

Yes

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

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

Last patient last visit.

Último paciente última visita.

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)

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.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)

None

Ninguno

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

2015-05-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-08-06

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

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