Clinical Trials Register

Summary
EudraCT Number:	2016-004416-35
Sponsor's Protocol Code Number:	OFT-EDE-2016
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:	2017-04-18
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

2016-004416-35

A.3

Full title of the trial

Efficacy and safety of three regimens based on tobramycin, dexamethasone and diclofenac for the prevention of pseudophakic macular edema. Randomized clinical trial

Eficacia y seguridad de tres pautas basadas en tobramicina, dexametasona y diclofenaco para la prevención del edema macular pseudofáquico. Ensayo clínico aleatorizado

A.3.1

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

Comparative study of different therapeutic regimens based on tobramycin, dexamethasone and diclofenac for the prevention of macular edema after cataract surgery.

Estudio comparativo de diferentes pautas terapéuticas basadas en tobramicina, dexametasona y diclofenaco para la prevención del edema macular post cirugía de catarata.

A.4.1

Sponsor's protocol code number

OFT-EDE-2016

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	Fundació Parc Taulí
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	Fundació Parc Taulí
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 Universitari Parc Taulí
B.5.2	Functional name of contact point	Oficina de Recerca
B.5.3	Address:
B.5.3.1	Street Address	Parc Taulí, 1
B.5.3.2	Town/ city	Sabadell
B.5.3.3	Post code	08208
B.5.3.4	Country	Spain
B.5.4	Telephone number	34937458451
B.5.5	Fax number	34937175067
B.5.6	E-mail	afarre@tauli.cat

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	Tobrex 3 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	ALCON CUSÍ, S.A.
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.3.4	Pharmaceutical form	Ear/eye drops, solution
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	Tobramycin
D.3.9.3	Other descriptive name	TOBRAMYCIN
D.3.9.4	EV Substance Code	SUB11134MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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	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	COLIRCUSÍ DEXAMETASONA 1 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	ALCON CUSÍ, S.A.
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.3.4	Pharmaceutical form	Eye drops, solution
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	DEXAMETHASONE SODIUM PHOSPHATE
D.3.9.3	Other descriptive name	DEXAMETHASONE SODIUM PHOSPHATE
D.3.9.4	EV Substance Code	SUB01615MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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.IMP: 3
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	Diclofenaco-Lepori
D.2.1.1.2	Name of the Marketing Authorisation holder	ANGELINI FARMACEUTICA, S.A .
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.3.4	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	DICLOFENAC SODIUM
D.3.9.3	Other descriptive name	DICLOFENAC SODIUM
D.3.9.4	EV Substance Code	SUB01674MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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.IMP: 4
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	tobradex
D.2.1.1.2	Name of the Marketing Authorisation holder	Alcon Cusi S.A.
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.3.4	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	DEXAMETHASONE
D.3.9.3	Other descriptive name	dexamethasone
D.3.9.4	EV Substance Code	SUB07017MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	tobramycin
D.3.9.3	Other descriptive name	TOBRAMYCIN
D.3.9.4	EV Substance Code	SUB11134MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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

Pseudophakic macular edema is a pathology that results from cataract surgery, usually occurring 4-6 weeks after surgery, which directly affects the retina (specifically the macula, the region that provides maximum visual acuity). In this condition, for different reasons, an inflammatory exudate accumulates in the different layers of the retina and can lead to affect the visual acuity, to severe retinal alterations both acute or chronic.

El edema macular pseudofáquico es una patología derivada de la cirugía de cataratas que ocurre generalmente entre las 4-6 semana posterior al acto quirúrgico, que afecta directamente a la retina (específicamente la mácula, región que brinda la máxima agudeza visual). En esta condición, por diversos mecanismos se acumula un exudado inflamatorio en las distintas capas de la retina que puede llevar a afectar la agudeza visual, hasta alteraciones retinianas mas severas tanto agudas como crónicas.

E.1.1.1

Medical condition in easily understood language

Pseudophakic macular edema is a condition that can occur postoperatively in cataract surgery consisting on fluid accumulation in the retina.

El edema macular pseudofáquico es una condición que puede ocurrir en el postoperatorio de la cirugía de cataratas que consiste en la acumulación de líquido en la retina.

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	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10051240
E.1.2	Term	Cystoid macular edema
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 compare the efficacy of different treatments based on tobramycin, dexamethasone and diclofenac in the prevention of pseudophakic macular edema.

Comparar la eficacia de diferentes pautas basadas en tobramicina, dexametasona y diclofenaco en la prevención del edema macular pseudoafáquico.

E.2.2

Secondary objectives of the trial

To compare the safety of different treatments based on tobramycin, dexamethasone and diclofenac in the prevention of pseudophakic macular edema.

To compare the anatomical and functional results of the different study treatments.

Comparar la seguridad de diferentes pautas basadas en tobramicina, dexametasona y diclofenaco en la prevención del edema macular pseudofáquico.

Comparar los resultados anatómicos y funcionales de las diferentes pautas del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients between 35-85 years
2. Patients with cataract in any of their forms that are submitted to intervention under phacoemulsification and intraocular lens implantation.
3. Patients who give their informed consent to participate in the study.

1. Pacientes con edad entre 35 – 85 años
2. Pacientes con catarata en cualquiera de sus formas que sean sometidos a intervención bajo técnica de facoemulcificación e implante de lente intraocular.
3. Pacientes que otorguen su consentimiento informado a participar en el estudio.

E.4

Principal exclusion criteria

1. Diabetic patients.
2. Patients with known previous macular pathology.
3. Patients with previous eye surgery in the eye to intervene.
4. Patients with cystic macular edema prior to surgery.
5. Pregnant or lactating women.
6. Patients unable to administer the treatment correctly.
7. Patients with any contraindication to the study treatments according to the approved technical data sheets.
8. Any circumstance that at the discretion of the physician may pose a risk or clinical harm to the patient's participation in the study or interfere with the assessments of the same.

1. Pacientes diabéticos.
2. Pacientes con patología macular previa conocida.
3. Pacientes con cirugía ocular previa del ojo a intervenir.
4. Pacientes con edema macular quístico previo a la cirugía.
5. Mujeres embarazadas o en período de lactancia.
6. Pacientes incapaces de administrarse el tratamiento de manera correcta.
7. Pacientes con alguna contraindicación a los tratamientos del estudio según las fichas técnicas aprobadas.
8. Cualquier circunstancia que a criterio del médico le pueda suponer un riesgo o perjuicio clínico la participación del paciente en el estudio o que interfiera en las valoraciones del mismo.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients presenting an increase of macular thickness with respect to pres surgery, measured with OCT.

Porcentaje de pacientes que presentan un aumento de grosor macular con respecto a las valoraciones pre-cirugía medido por OCT en las visitas sucesivas a la cirugía bajo técnica de facoemulcificación e implante de lente intraocular (se considerará aumento de grosor macular a un incremento mayor a 10 micras en cualquier punto de la zona macular).

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 semanas

E.5.2

Secondary end point(s)

Percentage of patients presenting clinical pseudofakic macular edema.
Number of adverse events
Best corrected visual acuity
Changes in macular thickness
Percentage of patients presenting ocular inflammation
Changes in the intraocular pressure

Porcentaje de pacientes que desarrollan edema macular pseudofáquico clínico (definido como cualquier aumento de grosor macular asociado a alteración de la visión y/o metamorfopsia) bajo técnica de facoemulcificación e implante de lente intraocular.
Número de acontecimientos adversos detectados con cada uno de los tratamientos.
Agudeza visual final corregida (Best corrected visual acuity (BCVA), logMAR (12 semanas).
Cambios respecto a las valoraciones pre cirugía en el grosor macular al día +1, a la semana, al mes y a las 12 semanas.
Porcentaje de pacientes con presencia de inflamación intraocular (células en cámara anterior) posterior a la cirugía de cataratas.
Cambios en la PIO con respecto al valor precirugía al día +1, a la semana, al mes y a las 12 semanas.

E.5.2.1

Timepoint(s) of evaluation of this end point

12 weeks

12 semanas

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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 subject last visit

Ultima visita del último paciente

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

110

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

210

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

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

2017-04-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-11

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

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