Clinical Trials Register

Summary
EudraCT Number:	2017-003277-34
Sponsor's Protocol Code Number:	T2380-PIV-017
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-11-22
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

2017-003277-34

A.3

Full title of the trial

Phase IV, open-label, randomized clinical trial to evaluate the effects of Fydrane® and standard topical mydriatics and anaesthetics protocol on ocular surface after cataract surgery.

Ensayo clínico de fase IV, abierto y aleatorizado para evaluar los efectos de Fydrane® y del protocolo estándar con midriáticos y anestésicos tópicos en la superficie ocular después de la cirugía de cataratas.

A.3.1

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

Clinical trial to evaluate the effects of Fydrane® and standard protocol on ocular surface after cataract surgery.

Ensayo clínico para evaluar los efectos de Fydrane® y del protocolo estándar en la superficie ocular después de la cirugía de cataratas.

A.3.2

Name or abbreviated title of the trial where available

EFOS

A.4.1

Sponsor's protocol code number

T2380-PIV-017

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	Laboratoires Théa
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Laboratoires Théa
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dynamic Science S.L.
B.5.2	Functional name of contact point	Fátima González Hurtado
B.5.3	Address:
B.5.3.1	Street Address	C/Azcona, 31
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28028
B.5.3.4	Country	Spain
B.5.4	Telephone number	003491 456 11 05
B.5.5	Fax number	003491 456 11 26
B.5.6	E-mail	f.gonzalez@dynasolutions.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	Fydrane
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracameral 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	0.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PHENYLEPHRINE HYDROCHLORIDE
D.3.9.1	CAS number	61-76-7
D.3.9.3	Other descriptive name	PHENYLEPHRINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03777MIG
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	3.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LIDOCAINE HYDROCHLORIDE
D.3.9.1	CAS number	73-78-9
D.3.9.4	EV Substance Code	SUB88133
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.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	Colircusi Anestésico Doble
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	Intraocular instillation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXYBUPROCAIN HYDROCHLORIDE
D.3.9.1	CAS number	5987-82-6
D.3.9.3	Other descriptive name	OXYBUPROCAIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03580MIG
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	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TETRACAINE HYDROCHLORIDE
D.3.9.1	CAS number	136-47-0
D.3.9.3	Other descriptive name	TETRACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04754MIG
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	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	Colircusi Anestésico Doble
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	Intraocular instillation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXYBUPROCAIN HYDROCHLORIDE
D.3.9.1	CAS number	5987-82-6
D.3.9.3	Other descriptive name	OXYBUPROCAIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03580MIG
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	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TETRACAINE HYDROCHLORIDE
D.3.9.1	CAS number	136-47-0
D.3.9.3	Other descriptive name	TETRACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04754MIG
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	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	Coliscusí fenilefrina
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	Intraocular instillation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PHENYLEPHRINE HYDROCHLORIDE
D.3.9.1	CAS number	61-76-7
D.3.9.3	Other descriptive name	PHENYLEPHRINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03777MIG
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: 5
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 Tropicamida
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	Intraocular instillation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraocular 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

Cataracts

Cataratas

E.1.1.1

Medical condition in easily understood language

Cataracts

Cataratas

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10007739
E.1.2	Term	Cataract
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
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

The primary objective of the study is to evaluate the effects of Fydrane (after oxybuprocain chlorhydrate 0.4% + tetracaine chlorhydrate 0.1% eye-drop instillation) and the standard mydriatic-anaesthetic eye-drop protocol(oxybuprocain chlorhydrate 0.4% + tetracaine chlorhydrate 0.1%, phenylephrine 10% and tropicamide 1%) on ocular surface.

El objetivo principal del estudio es evaluar los efectos de Fydrane® (tras la instilación de un colirio con oxibuprocaína clorhidrato 0,4% + tetracaína clorhidrato 0,1%) y del protocolo estándar con midriáticos y anestésicos tópicos (oxibuprocaína clorhidrato 0,4% + tetracaína clorhidrato 0,1%, fenilefrina 10% y tropicamida 1%) en la superficie ocular.

E.2.2

Secondary objectives of the trial

To assess changes in best corrected visual acuity recovery.
To evaluate epithelial alterations.
To describe changes in conjunctival hyperaemia.
To assess changes in intraocular pressure.
To evaluate the centre point-spread function by the objective scatter index (OSI) in the Optical Quality Analysis System (OQAS) HD AnalyzerTM.
To determine changes in the Ocular Surface Disease Index (OSDI) questionnaire.
To describe ocular symptoms/signs experienced by patients.
To assess patients’ perceptions on satisfaction with study treatments.
To determine satisfaction assessed by investigators.
To describe the safety profile of study treatments.

Evaluar los cambios en la recuperación de la mejor agudeza visual corregida.
Evaluar las alteraciones epiteliales.
Describir la variación de la hiperemia conjuntival.
Evaluar la variación de la presión intraocular.
Evaluar la función de dispersión de punto central mediante el índice de dispersión objetivo (OSI) en el sistema de análisis de calidad óptica (OQAS) HD Analyzer™.
Determinar la variación en el cuestionario OSDI (índice de enfermedad de la superficie ocular).
Describir los signos y síntomas oftalmológicos de los pacientes.
Evaluar la satisfacción de los pacientes con los tratamientos del estudio.
Determinar la satisfacción de los investigadores.
Describir el perfil de seguridad de los tratamientos del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patient aged 40 to 88 years, scheduled to undergo bilateral cataract surgery within the next 17 days (under topical anaesthesia and using clear corneal self-sealing incisions -phacoemulsification- foldable intraocular lens surgery with injector).
2. Pupil diameter ≥7 mm at selection visit after the following dilatation protocol: 1 drop of tropicamide 1% + 1 drop of phenylephrine 10%, with a maximum of 3 combined instillations at 10-minute intervals (i.e. time 0 minutes, time 0 + 10 minutes, and time 0 + 20 minutes), if necessary.
3. Scheduled use of intraocular lens injector Monarch II during the bilateral cataract surgery.
4. Patient willing and able to provide written informed consent prior to any study-related procedure and to comply with all study requirements.

1. Hombre o mujer de edad comprendida entre los 40 y los 88 años, con operación de cataratas bilateral programada en los siguientes 17 días (con anestesia tópica, incisiones autosellantes en córnea clara –facoemulsificación– e implante de lente intraocular plegable con inyector).
2. Diámetro de la pupila ≥ 7 mm en la visita de selección tras la aplicación del siguiente protocolo midriático: 1 gota de tropicamida 1% + 1 gota de fenilefrina 10%, con un máximo de 3 instilaciones de ambos productos a intervalos de 10 minutos (es decir: a los 0 minutos, a los 0 + 10 minutos y a los 0 + 20 minutos) en caso necesario.
3. Previsión de utilizar el inyector de lentes intraoculares Monarch II en la intervención bilateral de cataratas.
4. Voluntad y capacidad de otorgar el consentimiento informado por escrito antes de cualquier actividad del estudio y de cumplir con todos los requisitos del mismo.

E.4

Principal exclusion criteria

1. Patient who have combined surgery; previous intraocular and/or corneal surgery; iatrogenic, traumatic or congenital cataract; pupillary abnormalities (e.g. irregular); iris synechiae; eye movement disorder (e.g. nystagmus); dacryocystitis and all other pathologies of tear drainage system; history of inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis); corneal, epithelial, stromal or endothelial residual or evolutionary disease (including corneal ulceration and superficial punctate keratitis); corneal, epithelial, stromal or endothelial residual or evolutionary disease (including corneal ulceration and superficial punctate keratitis); history of ocular traumatism, infection or inflammation within the last 3 months; pseudoexfoliation, exfoliative syndrome; in any eye.
2. Clinically significant ocular endothelial dysfunction.
3. Patients with a cataract hardness in one of the eyes and/or grade ≥3 as per the Lens Opacities Classification System III (LOCS III).
4. The following concomitant medications will not be allowed: systemic corticoid treatments and immunosuppressive treatments within 3 months before surgery; systemic opioids and morphinic drugs within 7 days before surgery, topical ocular treatment with mydriatic and/or anaesthetic action within 7 days before surgery; other systemic analgesics (except paracetamol) within 7 days before surgery; contact lenses within 7 days before surgery; topical treatment with anti-inflammatory and antibiotic action within 1 day before surgery (except for the preoperative treatment specified in this protocol); anxiolytics and hypnotics on
the day of surgery; adrenaline or any other agent with a mydriatic action in the intraocular irrigating solution.
5. Any known ocular disorders affecting eye surface (i.e. staining grade >1 as per the Oxford schema).
6. Known hypersensitivity to the active substances (tropicamide, phenylephrine, lidocaine, oxybuprocain or tetracaine), any of their excipients, anaesthetics of the amide type or atropine derivatives.
7. Pregnancy or breastfeeding, in women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile).

1. Intervención quirúrgica combinada; antecedentes de cirugía intraocular y/o corneal; cataratas iatrogénicas, traumáticas o congénitas; anomalías pupilares (p. ej., irregulares); sinequias del iris; trastornos de los movimientos oculares (p. ej., nistagmo); dacriocistitis u otras patologías del sistema de drenaje lagrimal; antecedentes de enfermedades oftálmicas de tipo inflamatorio (p. ej., iritis, uveítis, queratitis herpética); enfermedad endotelial, estromal, epitelial o corneal de carácter residual o evolutivo (incluidas la ulceración corneal y la queratitis puntiforme superficial); antecedentes de traumatismos, infección o inflamación oculares en los últimos 3 meses; síndrome seudoexfoliativo o exfoliativo en cualquier ojo.
2. Disfunción clínicamente significativa del endotelio ocular.
3. Dureza de la catarata en uno de los ojos y/o grado ≥ 3 según el sistema de clasificación de opacidades del cristalino III (LOCS III).
4. No se permiten los siguientes tratamientos: corticoides sistémicos e inmunosupresores en los 3 meses antes de la operación; opiáceos sistémicos y fármacos mórficos en los 7 días antes de la operación; tratamientos oftálmicos tópicos con acción midriática o anestésica en los 7 días antes de la operación; otros analgésicos sistémicos (salvo paracetamol) en los 7 días antes de la operación; lentes de contacto en los 7 días antes de la operación; tratamiento tópico con acción antiinflamatoria y antibiótica en el día previo a la operación (salvo el tratamiento preoperatorio indicado en el presente protocolo); ansiolíticos e hipnóticos en el día de la operación; epinefrina u otros productos con acción midriática en la solución de irrigación intraocular.
5. Trastornos oftalmológicos con afectación de la superficie ocular (p. ej., tinción de grado > 1 según la escala de Oxford).
6. Hipersensibilidad conocida a los principios activos (tropicamida, fenilefrina, lidocaína, oxibuprocaína o tetracaína), a cualquiera de sus excipientes, a los anestésicos amídicos o a los derivados de la atropina.
7. Embarazo o lactancia en el caso de las mujeres con capacidad de concebir (es decir, fértiles, desde de la menarquia hasta la menopausia, a menos de esterilización permanente).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the change in corneal/conjunctival surface staining measured as per the Oxford schema (corneal staining with fluorescein) and van Bijsterveld schema (conjunctival staining with lissamine green) with Fydrane® versus the standard eye-drop protocol from baseline (visit 0) to 7 days post-surgery (visit 3). In addition, changes from baseline (visit 0) to just after surgery (visit 1) and from baseline (visit 0) to 12-36 hours post-surgery (visit 2) will be assessed.

El criterio principal de valoración es el cambio desde la valoración basal (visita 0) hasta el 7º día tras la cirugía (visita 3) en la tinción de la superficie corneal/conjuntival según el test de Oxford (tinción de la córnea con fluoresceína) y el test de Van Bijsterveld (tinción de la conjuntiva con verde de lisamina), comparando la aplicación de Fydrane® con el protocolo tópico estándar.

E.5.1.1

Timepoint(s) of evaluation of this end point

The evaluation per eye is performed on the day of the surgery, 12-36 hours after surgery and 7 (±1) days after surgery. Estimated period: 28 days.

La evaluación en cada ojo se realiza el día de la cirugía, 12-36 horas después de la cirugía y 7 (±1) días después de la cirugía. Período estimado: 28 días.

E.5.2

Secondary end point(s)

The change in best corrected visual acuity according to the Snellen test from baseline (visit 0) to 7 days post-surgery (visit 3).
The percentage of patients with epithelial alterations evidenced by slit-lamp examination (i.e. none, mild, and significant) 12-36 hours post-surgery (visit 2).
The change in conjunctival hyperaemia as per MacMonnies photographic scale (0 to 5) from baseline (right before study treatment administration at visit 1) to 7 days post-surgery (visit 3). In addition, changes in conjunctival hyperaemia from baseline (right before study treatment administration at visit 1) to just after surgery (visit 1) and from baseline (right before study treatment administration at visit 1) to 12-36 hours post-surgery (visit 2) will be described.
The change in intraocular pressure from baseline (visit 0) to 7 days post-surgery (visit 3).
Point-spread function measured by the objective scatter index (OSI) in the Optical Quality Analysis System (OQAS) HD AnalyzerTM 12-36 hours post-surgery (visit 2) and 7 days post-surgery (visit 3).  The change in the Ocular Surface Disease Index (OSDI) from baseline (right before study treatment administration at visit 1) to 7 days post-surgery (visit 3).
Percentages of patients with ocular symptoms as perceived by patients and signs assessed by investigators according to ordinal scales ranging from 0 (absent/none) to 3 (severe) 12-36 hours post-surgery (visit 2) and 7 days post-surgery (visit 3).
Patients’ satisfaction with study treatments assessed on an ordinal scale ranging from 0 (very satisfactory) to 3 (unsatisfactory) just after surgery (visit 1).
Satisfaction assessed by the investigators according to an ordinal scale ranging from 0 (very satisfactory) to 3 (unsatisfactory) just after surgery (visit 1).
The incidence of adverse events related to study treatments.

Cambio en la mejor agudeza visual corregida según el test de Snellen desde la valoración basal (visita 0) hasta el 7º día después de la operación (visita 3).
Porcentaje de pacientes con alteraciones epiteliales observadas con la lámpara de hendidura (a saber: ninguna, leve o significativa) a las 12-36 horas de la operación (visita 2).
Variación de la hiperemia conjuntival según la escala fotográfica de MacMonnies (0 a 5) desde la valoración basal (justo antes de administrar el tratamiento del estudio en la visita 1) hasta el 7º día después de la operación (visita 3). Además, se describirán las variaciones en la hiperemia conjuntival desde la valoración basal (justo antes de administrar el tratamiento del estudio en la visita 1) hasta inmediatamente después de la operación (visita 1) y desde la valoración basal (justo antes de administrar el tratamiento del estudio en la visita 1) hasta las 12-36 horas después de la operación (visita 2).
Variación de la presión intraocular desde la valoración basal (visita 0) hasta el 7º día después de la operación (visita 3).
Función de dispersión de punto determinada según el índice de dispersión objetivo (OSI) en el sistema de análisis de calidad óptica (OQAS) HD Analyzer™, al cabo de 12-36 horas de la operación (visita 2) y el 7º día después de la operación (visita 3).
Variación del índice de enfermedad de la superficie ocular (OSDI) desde la valoración basal (justo antes de administrar el tratamiento del estudio en la visita 1) hasta el 7º día después de la operación (visita 3).
Porcentajes de pacientes que perciben síntomas oculares y que presentan signos oculares según la valoración de los investigadores, calculados con escalas ordinales del 0 (ausencia/ninguno) al 3 (severo), al cabo de 12-36 horas de la operación (visita 2) y en el 7º día después de la operación (visita 3).
Satisfacción de los pacientes con los tratamientos del estudio, determinada con una escala ordinal del 0 (muy satisfecho) al 3 (insatisfecho) inmediatamente después de la operación (visita 1).
Satisfacción de los investigadores, puntuada con una escala ordinal del 0 (muy satisfecho) al 3 (insatisfecho) en el posoperatorio inmediato (visita 1).
Incidencia de los acontecimientos adversos relacionados con los tratamientos del estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

The evaluation per eye is performed on the day of the surgery, 12-36 hours after surgery and 7 (±1) days after surgery. Estimated period: 28 days.

La evaluación en cada ojo se realiza el día de la cirugía, 12-36 horas después de la cirugía y 7 (±1) días después de la cirugía. Período estimado: 28 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)

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

Yes

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

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

UVUP

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

2018-01-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-04-26

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