Clinical Trials Register

Summary
EudraCT Number:	2013-000292-33
Sponsor's Protocol Code Number:	HGC_SAR_1_13
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:	2013-09-16
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

2013-000292-33

A.3

Full title of the trial

Comparative study of the mydriatic effect of Mydriasert vs the use of topical instillation of phenylephrine (10%) and tropicamide (1%) before catarcat surgery.

Estudio comparativo del efecto midriático de Mydriasert® versus la aplicación tópica de gotas de fenilefrina (10%) y tropicamida (1%) en el marco de cirugía de cataratas.

A.3.1

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

Comparative estudy of pupil dilatation induced by Mydriasert and an association of phenylephrine and tropicamide before cataract surgery

Estudio de la comparación del tamaño de dilatación pupilar inducido por Mydriasert en comparación con el efecto inducido por la asociación de fenilefrina y tropicamida en el marco de una cirugía de cataratas

A.4.1

Sponsor's protocol code number

HGC_SAR_1_13

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	Laura Sararols Ramsay
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	Capio Hospital General de Catalunya
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 General de Catalunya
B.5.2	Functional name of contact point	Roger Herrero
B.5.3	Address:
B.5.3.1	Street Address	c/ Pedro i Pons, 1
B.5.3.2	Town/ city	Sant Cugat del Vallés
B.5.3.3	Post code	08915
B.5.3.4	Country	Spain
B.5.4	Telephone number	34937071936
B.5.5	Fax number	34937070193
B.5.6	E-mail	rogerherrero@hotmail.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	Mydriasert
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	Mydriasert
D.3.4	Pharmaceutical form	Ophthalmic insert
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Conjunctival use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tropicamide
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	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0 to 1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	phenYlephrine chlorhydrate
D.3.9.1	CAS number	61-76-7
D.3.9.3	Other descriptive name	PHENYLEPHRINE CHLORHYDRATE
D.3.9.4	EV Substance Code	SUB03777MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 6
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	Yes
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	Colircusí Fenilefrina 100mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Alcon Cusí SA
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	Phenylephrine chlorhydrate
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	PHENYLEPHRINE CHLORHYDRATE
D.3.9.1	CAS number	61-76-7
D.3.9.3	Other descriptive name	Phenylephrine chlorhydrate
D.3.9.4	EV Substance Code	SUB09788MIG
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	100
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	Colisrcusí Tropicamida 10 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Alcon Cusí
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	Tropicamide
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	Tropicamide
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	mg/ml milligram(s)/millilitre
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.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

Cataract surgery

Cirugía de cataratas

E.1.1.1

Medical condition in easily understood language

Cataract surgery

Cirugía de cataratas

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	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10039960
E.1.2	Term	Senile cataract
E.1.2	System Organ Class	100000004853

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10063797
E.1.2	Term	Cataract operation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

-Determine pupilar diameter induced by Mydriasert at capsulorrhexis (equal or higher than 6.5 mm).
-Determine pupil diameter and mydrisis stability induced by Mydriasert at t30, t45, t60 and t90 after the use of the ocular insert in the eye of the patient. Determine if Mydriasert is able to induce a mydriasis equal or higher than the topical treatment used as comparator.
Measurement of mydriasis stability also will be determined not only at previously mentioned times but also during surgery time: surgery has been divided in 5 times when investigator must measure pupilar dilatation.

-Determinar el diámetro de la midriasis inducida por Mydriasert® en el momento de la realización de la capsulorrexis ( igual o superior a 6.5 mm).
-Determinar el diámetro y la estabilidad de la midriasis inducida por Mydriasert® a los 30, 45, 60 y 90 minutos de la aplicación del inserto en el saco conjuntival. Determinar si Mydriasert® es capaz de conseguir un diámetro de dilatación pupilar igual o superior al inducido por el tratamiento tópico.
La estabilidad de la midriasis no sólo será medida a los tiempos definidos anteriormente (t30, t45, t60 y t90) sino que se realizará una determinación continuada durante el tiempo que durará la cirugía. Para ello se ha dividido la cirugía en 5 tiempos en cada uno de los cuales el investigador deberá medir la dilatación pupilar.

E.2.2

Secondary objectives of the trial

-Determine if there is a relationship between the use of Mydriasert for pupil dilatation and presence of macular oedema. Identify the number of cases of macular oedema at each group of treatment, the macular thickness and stability of the dilatation for each patient. Investigator will perform the measurements during the surgery at 5 different times.
-Determine systemic and local tolerance and safety
-Determine the efficacy of Mydriasert by the investigator assessment
-Determine the suitability of Mydriasert by the nurse: handling, total time invested on the procedure, etc (suitability questionnaire).

-Determinar si existe relación entre el uso del método Mydriasert® para inducir midriasis y la aparición de edema macular quístico. Se determinará el número de casos en cada grupo de estudio, el volumen de la mácula en los individuos de cada grupo y la estabilidad de la dilatación pupilar a lo largo de la cirugía. Para ello se dividirá la cirugía en 5 tiempos en los que el investigador tomará la medida de dilatación.
-Determinar la tolerancia y seguridad local y periférica del uso del inserto.
-Determinar la efectividad del uso del inserto mediante la valoración del investigador.
-Determinar la idoneidad del uso de la aplicación tópica respecto a la aplicación del inserto para conseguir la midriasis efectiva por lo que respecta a la frecuencia de intervención de la enfermera y el tiempo total de dedicación de la misma por cada paciente (cuestionario de idoneidad).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men and women aged from 45 to 85 years old
2. Scheduled to undergo unilateral catarcat surgery. Diagnosis of senil cataract solved by phacoemulsification + intraocular lens implant.
3. Patients who understand and sign informed consent.

1. Hombres y mujeres de entre 45 y 85 años
2. Cirugía de cataratas unilateral con diagnóstico de catarata senil para resolución mediante facoemulsificación+implante de lente intraocular (LIO)
3. Pacientes que hayan dado el consentimiento informado por escrito en el que se explicará qué tipo de pruebas han de realizar

E.4

Principal exclusion criteria

Ophthalmic conditions (elegible eye):
1.Combined surgery
2. Pupillary abnormalities (irregular,..)
3. Very dark iris
4. Iris synechiae
5. Eye movement disorder (Nystagmus,..)
6. Dacryocystitis and all others pathologies of tears drainage system
7. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis,….)
8. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
9. Pseudoexfoliation, exfoliative syndrome
10. History of ocular traumatism, infection or inflammation within the last 3 months
11. History of uveitis
12 Macular thickness >320 micrometers
13. History of any other co-existent pathology afecting visual acuity or macular thickness (corneal opacity, AMD, glaucoma, ocular hypertension,...)
Ophthalmic conditions (fellow eye):
14. Best corrected visual acuity ≥ +1,0 LogMar ó ≤ 35 letters EDTRS or ≥ 20/200 Snellen or ≥ 0,1
15. Patient already included in the study for phakoexeresis
16. History of surgical complication (cystoid macular oedema...)
Ocular and systemic treatments:
17. Patients under systemic treatment with mydriatic and/or miotic activity in the last 3 months before the surgery: alpha-adrenergic receptor antagonist, anticholinergic, antipsychotic medication...
18. Patients under systemic treatment with corticosteroids or immunosupressive medication in the last 3 months before the surgery
19. Patients under systemic treatments with opioids, morphinic medication, MAO inhibitors and/or tricyclic antidepressants in the last 15 days before the surgery
20. Patients using topic treatments with mydriatic and/or analgesic activity in the last 15 days before the surgery
21. Patients under any other systemic analgesic treatment in the last 7 days before the surgery (except paracetamol)
22. Contact lens wearers in the last 7 days before the surgery
23. Patients using topic antiinflamatory and antibiotic treatments the day before the surgery
24. All the treatments previously mentioned are also forbidden during the follow-up period of the study
25. Patients foreseen a change in the not forbidden systemic medication after screening visit
Systemic / non ophthalmic conditions:
26. Diabetes not controlled,
27. Insulin-dependent diabetes
28. Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled arterial hypertension etc...) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
29. Allergic history. Known hypersensitivity to one of the components of the study
medications or to test products.
30. Allergic rhinitis.
31. Pregnancy, lactation.
32. Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR Women not hysterectomised, menopaused or surgically sterilized.
Non-inclusion criteria related to general conditions:
33. Drugs comsumption
34. Participation in another clinical study in last 30 days
35. Inability of patient and/or relatives to understand the study procedures, and thus inability to give informed consent
36. Non compliant patients and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
37. Ward of court

Afecciones/Enfermedades oculares (ojo elegible)
1. Cirugía combinada en el ojo elegible
2. Malformaciones pupilares
3. Iris muy oscuros
4. Sinequias de iris
5. Nistagmo u otras alteraciones del movimiento del ojo
6. Dacriocistitis
7. Antecedentes de enfermedad ocular inflamatoria
8. Enfermedad residual o evolutiva del epitelio, del estroma o del endotelio corneal (incluyendo ulceración corneal y queratitis punteada superficial)
9. Pseudoexfoliación de la lente
10. Antecedentes de traumatismo, infección, inflamación ocular en los últimos 3 meses.
11. Historia de uveítis
12. Espesor macular de > 320 μm en el ojo a estudio determinado por Tomografía de Coherencia Óptica (TCO) antes de la cirugía.
13. Cualquier otra patología ocular co-existente que pueda afectar a la agudeza visual o al espesor de la mácula (i.e. opacidad corneal, DMAE, glaucoma o hipertensión ocular).
Afecciones/Enfermedades oculares (ojo contralateral)
14. Puntuación de la Mejor Agudeza Visual Corregida (BCVA) ≥ +1,0 LogMar ó ≤ 35 letras EDTRS ó ≥ 20/200 Snellen ó ≥ 0,1
15. Paciente ya incluido en un estudio de facoexéresis en los últimos 3 meses
16. Antecedentes de complicación de cirugía oftálmica
Tratamientos oculares y sistémicos
17. Pacientes con tratamientos sistémicos con fármacos de acción midriática o miótica en los últimos 3 meses previos a la cirugía: antagonistas de receptores alfa-adrenérgicos, anticolinérgicos, antipsicóticos.
18. Pacientes con tratamientos de corticosteroides sistémicos o inmunosupresores en los últimos 3 meses previos a la cirugía.
19. Pacientes con tratamientos de opioides, morfínicos, inhibidores de la MAO y/o antidepresivos tricíclicos sistémicos en los últimos 15 días previos a la cirugía.
20. Pacientes con tratamientos oculares tópicos con acción midríatica y/o analgésica en los últimos 15 días previos a la cirugía.
21. Pacientes con otros tratamientos analgésicos sistémicos (excepto el paracetamol) en los últimos 7 días previos a la cirugía.
22. Pacientes que hayan sido portadores de lentes de contacto en los últimos 7 días previos a la cirugía
23. Pacientes con tratamientos tópicos de acción antiinflamatoria y antibiótica el día antes de la cirugía.
24. Todos los tratamientos citados anteriormente estarán también prohibidos durante el desarrollo del estudio.
25. Pacientes que prevean cualquier cambio en la medicación sistémica permitida que toma el paciente antes de la visita de selección.

Afecciones/Enfermedades o tratamientos sistémicos
26. Diabetes no controlada
27. Diabetes insulinodependiente
28. Cualquier antecedente o enfermedad o trastorno médico o quirúrgico, como enfermedad orgánica grave aguda o crónica: enfermedad hepática, endocrina, neoplásica, hematológica, enfermedad psiquiátrica grave, alteraciones cardiovasculares importantes y/o cualquier factor que pueda complicar la cirugía o cualquier alteración estructural que a juicio del investigador sea incompatible con el estudio
29. Hipersensibilidad conocida a alguno de los componentes de los medicamentos o productos del estudio
30. Rinitis alérgica
31. Situación de embarazo o lactancia en la visita de selección.
32. Mujeres con capacidad de procrear que no utilicen un método médicamente aceptable y altamente eficaz de control de natalidad (i.e. implantes hormonales, anticonceptivos orales o inyectables junto con preservativos, algunos dispositivos intrauterinos) a partir de la visita de inclusión y a lo largo de la realización de los períodos de tratamiento del estudio y hasta dos semanas después del estudio. Las mujeres post-menopáusicas (dos años sin menstruación) no necesitan utilizar ningún método de control de la natalidad.

Cumplimiento/Administrativo
33. Sospecha o confirmación de consumo de drogas ilegales.
34. Participación en otro estudio clínico en los 30 días previos a la visita de selección.
35. Incapacidad del paciente y/o familiares de comprender los procedimientos del estudio y por lo tanto incapacidad para dar el consentimiento informado.
36. Pacientes no cumplidores, es decir, que no acudan a las visitas de seguimiento o que su forma de vida interfiera con el cumplimiento del protocolo.
37. Paciente bajo tutela judicial.

E.5 End points

E.5.1

Primary end point(s)

Primary end point is evaluate the mydriasis at capsulorrhexis (limiting procedure during cataract surgery). Mydriasert will be efficient if just before the capsulorrhexis pupil diameter is equal or higher than 6.5 mm.
Also stability of the mydriasis will be evaluated from t30 to t90 and during full surgery time. Mydriasis obtained with topical treatment will be compared with mydriasis obtained using Mydriasert and it will be asessed if mydriasis obtained in both cases is continous in the time, especially during surgery time: this could facilitate a more confortable surgery filed for the investigator.
Surgery will be divided in 5 different times for measuring pupil dilatation:
T1: before 1st incision
T2: before the use of viscoelastic
T3: before the capsulorrherxis
T4: after the phacoemulsification
T5: after intraocular lens implant

Se valorará la capacidad de dilatación pupilar en el momento de iniciar la capsulorrexis por considerarse éste un momento decisivo en la cirugía. Globalmente Mydriasert® se considerará clínicamente eficaz si el diámetro de dilatación obtenida justo antes del procedimiento de la capsulorrexis es de al menos 6.5 mm.
Asimismo, se valorará la eficacia de Mydriasert® teniendo en cuenta la capacidad para mantener la dilatación obtenida a partir de t30 hasta t90 (t30, t45, t60 y t90) y también durante toda la cirugía, de manera a comprobar cual es el diámetro de dilatación conseguido respecto al tratamiento tópico y si esa dilatación es o no constante, especialmente durante toda la intervención, lo que asegurará un campo quirúrgico adecuado para el investigador.
Para valorar el diámetro pupilar durante toda la cirugía se escogerán 5 tiempos en los cuales el cirujano investigador deberá tomar la medida pupilar mediante uso de compás quirúrgico:
T1: antes de la 1ª incisión
T2: antes de la aplicación del viscoelástico
T3: antes de la capsulorrexis
T4: después de la facoemulsificación
T5: después de la introducción de la lente

E.5.1.1

Timepoint(s) of evaluation of this end point

Primary end point will be evaluated at inclusion visit, surgery visit or D0

La eficacia clínica de Mydriasert® se determinará en D0

E.5.2

Secondary end point(s)

-Systemic tolerability of the IMP: determine cardiovascular parameters before, during and after surgery.
-Local tolerability of the IMP: determine ocular symptoms. Patients should describe symptoms associated to Mydriasert (placing, maintenance and removal of the insert). During the long of the study investigator will evaluate ocular signs and symptoms.
-Local and systemic safety: adverse events will be monitored. Local adverse event related with macular oedema will be especially monitored
-Investigator assessment related to efficiency and satisfaction
-Suitability of Mydriasert by the nurse assessment

-Variable de tolerancia: para ello se determinarán las reacciones a nivel cardiovascular antes, durante y después de la cirugía (frecuencia cardiaca, presión sistólica y diastólica)
A nivel de superficie ocular (síntomas oculares). El mismo día de la cirugía se les pedirá a los pacientes que describan la sintomatología asociada a la colocación, permanencia y retirada del inserto. Durante todo el estudio se valorarán los signos y síntomas clínicos a nivel de superficie ocular mediante el uso de la lámpara de hendidura.
-Variable de seguridad: se tendrán en cuenta los acontecimientos adversos referidos por los pacientes del estudio. Una de las determinaciones de seguridad será el de identificar la presencia de edema macular mediante el uso de la tomografía de coherencia óptica.
-Variable de efectividad y satisfacción según criterio del investigador.
-El estudio tendrá también en cuenta la evaluación de la variable cualitativa que se referirá a la idoneidad del uso de Mydriasert® versus la aplicación tópica de fenilefrina y tropicamida, teniendo en cuenta el tiempo de trabajo invertido por paciente y la facilidad de uso del inserto por parte de la enfermera encargada del procedimiento. de

E.5.2.1

Timepoint(s) of evaluation of this end point

-Local tolerability will be evaluated at D0, surgery visit or inclusion visit. Also at D1, D14, D30 and D90
-Local and systemic safety will be evaluated at D0, D1, D14, D30 and D90. Macular thickness measurement will be done at D1, D30 and D90
-Investigator assessment will be evaluated at D0
-Suitability of Mydriasert will be evaluated at D0

-Tolerancia local: evaluación en D0, visita de cirugía o visita de inclusión. Se continuará durante las visitas D1, D14, D30 y D90
-Seguridad sistémica y local: evaluación en D0, D1, D14, D30 y D90. El espesor de la mácula se determinará en D1, D30 y D90
-Evaluación por parte del investigador: D0
-Evaluación de la idoneidad del inserto: D0

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)

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

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

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

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 is scheduled at D90 for each patient (LVLP). No other extra visits have been scheduled except visits scheduled by the investigator in order to control and follow local adverse events.

El estudio se acaba en D90 para cada paciente (última visita del último paciente). No se prevén visitas extraordinarias a parte de las posibles visitas de seguimiento de acontecimientos adversos de tipo local.

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

2013-11-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-24

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

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