Clinical Trials Register

Summary
EudraCT Number:	2021-003469-36
Sponsor's Protocol Code Number:	THEA_HLF_1/21
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:	2021-07-15
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

2021-003469-36

A.3

Full title of the trial

“Prospective evaluation of the efficacy and safety of topical hydrocortisone treatment on clinical signs and
symptoms of dry eye disease associated with moderate meibomian gland dysfunction”

"Evaluación prospectiva de la eficacia y la seguridad del tratamiento tópico con hidrocortisona en los signos y síntomas clínicos de la xeroftalmia asociada a una disfunción moderada de las glándulas de Meibomio"

A.3.1

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

“Evaluation of the efficacy and safety of topical treatment on clinical signs and symptoms of dry eye disease associated with moderate meibomian gland dysfunction”

"Evaluación de la eficacia y la seguridad del tratamiento tópico en los signos y síntomas clínicos del ojo seco asociado a una disfunción moderada de las glándulas de Meibomio"

A.3.2

Name or abbreviated title of the trial where available

SOFT–MGD

A.4.1

Sponsor's protocol code number

THEA_HLF_1/21

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	Laboratorios Théa, S.A.
B.1.3.4	Country	Spain
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	Laboratorios Théa, S.A.
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	Laboratorios Théa, S.A.
B.5.2	Functional name of contact point	María Greaves
B.5.3	Address:
B.5.3.1	Street Address	C/ Enric Granados, 86-88, 2ª planta
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08008
B.5.3.4	Country	Spain
B.5.6	E-mail	maria.greaves@theapharma.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	Softacort
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios Théa, 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.3.1	Product name	Softacort
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	HYDROCORTISONE SODIUM PHOSPHATE
D.3.9.1	CAS number	6000-74-4
D.3.9.4	EV Substance Code	SUB02568MIG
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	3.35
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	Lephanet
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	Lephanet
D.3.2	Product code	246116.1
D.3.4	Pharmaceutical form	Medicated sponge
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
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	Yes
D.3.11.13.1	Other medicinal product type	sterile wipes
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	Thealoz Duo
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	Thealoz Duo
D.3.2	Product code	166701.4
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.3.11 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	Yes
D.3.11.13.1	Other medicinal product type	Trehalose 3% and sodium hyaluronate 0.15% in a sterile, preservative free, hypotonic and pH neutral aqueous ophthalmic solution.
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	MGD Rx EyeBag
D.2.1.1.2	Name of the Marketing Authorisation holder	The EyeBag Company Ltd
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	MGD Rx EyeBag
D.3.4	Pharmaceutical form	Gel in sachet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	External use
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	Yes
D.3.11.13.1	Other medicinal product type	A silk and cotton device which can be re-heated in a microwave.

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

Dry Eye (DE) and Meibomian gland dysfunction (MGD)

Xeroftalmia y disfunción de las glándulas de Meibomio (MGD)

E.1.1.1

Medical condition in easily understood language

Dry Eye (DE) and Meibomian gland dysfunction (MGD)

Ojo seco y disfunción de las glándulas de Meibomio (MGD)

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10013774
E.1.2	Term	Dry eye
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10065062
E.1.2	Term	Meibomian gland dysfunction
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

-Efficacy objective: To compare change in MGD-DE symptom score (defined as the sum of the Visual Analogue Scale (VAS) score obtained from each of the following symptoms: itching, dry eye sensation, burning, foreign body sensation and ocular redness), from baseline (D0) to Day 14 (D14) in patients with DE and moderate MGD treated with lid hygiene, artificial tears, and a medical device (MGD Rx EyeBag®) with or without hydrocortis-one.
-Safety objective: Incidence of increased intraocular pressure (IOP) between D0, D14, D28 and D84.

-Objetivo de eficacia: Comparar la variación de la puntuación de síntomas de la xeroftalmia asociada a la MGD (definida como la suma de la puntuación de la escala analógica visual [EAV] obtenida en cada uno de los síntomas siguientes: prurito, sensación de sequedad ocular, escozor, sensación de cuerpo extraño y enrojecimiento ocular) entre el momento basal (D0) y el día 14 (D14) en pacientes con xeroftalmia y MGD moderada tratados con higiene palpebral, lágrimas artificiales y un producto sanitario (MGD Rx EyeBag®) con o sin hidrocortisona.
-Objetivo de seguridad: Incidencia del aumento de la presión intraocular (PIO) entre el D0, el D14, el D28 y el D84.

E.2.2

Secondary objectives of the trial

-Efficacy objective:
•To assess ocular symptoms of DE and MGD measured by:
change in OSDI score
change in VAS score of each of 7 symptoms
•To assess ocular signs of ocular surface disease:
conjunctival hyperemia measured with the McMonnies-Chapman scale
tear film stability measured by tear breakup time test
ocular surface damage measured by fluorescein corneal and conjunctival staining
ocular surface damage measured by lissamine green corneal and conjunctival staining
tear meniscus height
tear volume
•To assess ocular signs of MGD:
Grading of MGD
Lid abnormalities including irregularity, thickness, and plugging
Eyelid telangiectasia
Lissamine green staining of lid margin
Meibomian gland expressibility
•Inflammatory cytokine level in tears
-Safety Objectives:To assess the safety of the medication received by the patient and Change in visual acuity

Eficacia:
•Evaluar síntomas oculares de xeroftalmia y DGM determinados mediante:
Variación puntuación OSDI
Variación puntuación en la EAV de cada uno de los 7 síntomas
•Evaluar signos oculares de enfermedad de la superficie ocular:
Hiperemia conjuntival medida con la escala McMonnies-Chapman
Estabilidad de la película lagrimal medida por prueba del tiempo de rotura de la película lagrimal
Daño en la superficie ocular medido por tinción corneal y conjuntival con fluoresceína y con verde de lisamina
Altura del menisco lagrimal
Volumen lagrimal
•Evaluar los signos oculares de la DGM:
Graduación de la DMG
Anomalías palpebrales, como irregularidades, grosor y obstrucción
Telangiectasia palpebral
Tinción con verde de lisamina del borde palpebral
Expresividad de la glándula de Meibomio
•Nivel de citocinas inflamatorias en las lágrimas
Seguridad:Evaluar seguridad de la medicación que recibe el paciente y Variación de agudeza visual

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥ 18 years
2. Documented diagnosis of DE defined by TBUT value ≤ 5 seconds and Schirmer I test value < 10 mm/5 min
3. Normal ophthalmic findings except DED and MGD
4. OSDI score > 23 (moderate symptoms)
5. Documented diagnosis of MGD grade 2 to 3
6. Patient who can understand the instructions and adhere to medications
7. Patient who receives complete information regarding the study objectives, authorize their participation in the study and sign a written informed consent form (ICF) before entering in the study

1. Edad ≥18 años.
2. Varones o mujeres.
3. Diagnóstico documentado de xeroftalmia, definida por un valor de TBUT ≤5 segundos y un valor de la prueba de Schirmer I <10 mm/5 min.
4. Hallazgos oftalmológicos normales, excepto xeroftalmia y DGM.
5. Puntuación OSDI >23 (síntomas moderados).
6. Diagnóstico documentado de MGD de grado 2 a 3.
7. Paciente capaz de comprender las instrucciones y cumplir el tratamiento.
8. Paciente que reciba toda la información sobre los objetivos del estudio, autorice su participación en el estudio y firme un documento de consentimiento informado (DCI) por escrito antes de incorporarse al estudio.

E.4

Principal exclusion criteria

1. Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag ® or Softacort® as per SmPC
2. Ocular surgery in the past 6 months
3. Ocular hypertension or glaucoma
4. Cicatricial MGD
5. Atopic condition including ocular allergy
6. Suspect demodex lid infestation as evidenced by the presence of collarettes
7. Intraocular inflammation
8. Confirmed infection with COVID-19 in the last 3 months
9. Systemic autoimmune disorder
10. Use of contact lenses during the month prior to inclusion in the study or during the study
11. Punctal occlusion
12. IOP > 22mmHg
13. Patient who has received topical or systemic anti-inflammatory treatments including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 3 months prior to be included in the study or with a prescription for receiving topical / systemic anti-inflammatory treatments for the next 3 months
14. In the investigator´s opinion, use of systemic medications that could affect the function of the MG and tear production within 3 months prior to be included in the study
15. Any ocular or systemic disease known to affect the tear film, other than MGD
16. Patient with any situation or state that in the opinion of the investigator discourages their participation in the study
17. Patient participating in any other interventional or non-interventional study or who have participated in another study within 30 days prior to inclusion in this study
18. Women who are pregnant, planning to become pregnant or breastfeeding
19. Patient who will not be able to complete the study (e.g., not willing to attend the follow-up visits, way of life interfering with compliance)

1. Cualquier contraindicación o alergia conocida a Lephanet®, Thealoz Duo®, MGD Rx EyeBag® o Softacort® según la ficha técnica.
2. Cirugía ocular en los últimos 6 meses.
3. Hipertensión ocular o glaucoma.
4. MGD cicatricial.
5. Trastorno atópico, como alergia ocular.
6. Sospecha de infestación palpebral por Demodex, demostrada por la presencia de secreción «en collarines».
7. Inflamación intraocular.
8. Infección confirmada por COVID-19 en los 3 últimos meses.
9. Trastorno autoinmunitario sistémico.
10. Uso de lentes de contacto durante el mes previo a la inclusión en el estudio o durante el estudio.
11. Oclusión de los puntos lagrimales.
12. PIO >22 mm Hg.
13. Pacientes que hayan recibido tratamientos antiinflamatorios tópicos o sistémicos, como corticosteroides y antiinflamatorios no esteroideos (AINE), en los 3 meses previos a su inclusión en el estudio o a los que se haya prescrito tratamientos antiinflamatorios tópicos o sistémicos durante los 3 próximos meses.
14. En opinión del investigador, uso de medicamentos sistémicos que puedan afectar a la función de la MG y a la producción de lágrimas en los 3 meses previos a la inclusión en el estudio.
15. Cualquier enfermedad ocular o sistémica, distinta de la DGM, que se sepa que afecta a la película lagrimal.
16. Paciente con cualquier situación o estado que, en opinión del investigador, desaconseje su participación en el estudio.
17. Participación en otro estudio intervencionista o de observación o participación en otro estudio en los 30 días previos a la inclusión en este estudio.
18. Mujeres embarazadas, que tengan previsto quedarse embarazadas o que estén amamantando.
19. Pacientes que no puedan completar el estudio (p. ej., que no estén dispuestos a acudir a las visitas de seguimiento o tengan un modo de vida que dificulte el cumplimiento).

E.5 End points

E.5.1

Primary end point(s)

-Efficacy: Change in MGD-DE symptom score from D0 to D14.
-Safety: Incidence of increased intraocular pressure (IOP). Change in IOP between D0, D14, D28 and D84.

-Eficacia: Variación de la puntuación de síntomas de la xeroftalmia asociada a la MGD entre el D0 y el D14.
-Seguridad: Incidencia de aumento de la presión intraocular (PIO). Variación de la PIO entre el D0, el D14, el D28 y el D84.

E.5.1.1

Timepoint(s) of evaluation of this end point

For all primary endpoints: from day 1 to day 84.

Para todas las variables primarias desde el día 1 al 84.

E.5.2

Secondary end point(s)

Efficacy endpoints:
Ocular Symptoms
• Change in OSDI score between D0 and D14, D28 and D84.
• Change in MGD-DE symptom score from D0 to D28 and D84.
• Change in VAS score of each of 7 symptoms (itching, dry eye sensation, burning, foreign body sensation, ocular redness, ocular fatigue, and blurry vision) between D0 and D14, D28 and D84.
Ocular signs of DED
• Change in hyperemia score (McMonnies – Chapman scale) between D0 and D14, D28 and D84.
• Change in TBUT between D0 and D14, D28 and D84.
• Change in corneal and conjunctival staining with fluorescein (Oxford grading scale) between D0 and D14, D28 and D84.
• Change in corneal and conjunctival staining with lissamine green (Van Bijsterveld scale) between D0 and D14, D28 and D84.
• Change in value of tear meniscus height between D0 and D14, D28 and D84.
• Change in Schirmer I test between D0 and D14, D28 and D84.
Ocular signs of MGD
• Change in grading of MGD according to a graduation from 0 to 4 where 0 is no meibomian gland dropout and expressed meibum with clear appearance and 4 is with gland dropout of more than half the lid margin or complete keratinization of the ducts and no expression of meibum.
• Change in lid abnormality score (irregularity, thickness and plugging) according to a graduation from 0 to 2, where 0 is no findings and 2 is severe findings.
• Change in Eyelid telangiectasia score according to a graduation from 0 to 3, where 0 is no findings and 3 is severe findings, between D0 and D14, D28 and D84.
• Change in lissamine green staining of lid margin score between D0 and D14, D28 and D84.
• Change in MG expressibility between D0 and D14, D28 and D84.
Inflamatory Cytokines
• Change from D0 value to D14 (both eyes) in level of the following inflammatory cytokines in tears: IL-6, TNF alpha, IL-1b, IL-10, IFNγ, IL-17A, IL-2, IL-4. First eye to sample will be the study eye.
Safety endpoints
• Incidence of adverse events (AE) and serious adverse events (SAE) occurred during the study.
• Change in visual acuity between D0, D14, D28 and D84. Early Treatment Diabetic Retinopathy Study (ETDRS) scale will be used.

Eficacia:
Síntomas oculares
• Variación de la puntuación OSDI entre el D0 y el D14, y entre el D28 y el D84.
• Variación de la puntuación de síntomas de la xeroftalmia asociada a la MGD entre el D0 y D28, y entre el D0 y el D84.
• Variación de la puntuación en la EAV de cada uno de los 7 síntomas (prurito, sensación de sequedad ocular, escozor, sensación de cuerpo extraño, enrojecimiento ocular, cansancio ocular y visión borrosa) entre el D0 y el D14, y entre el D28 y el D84.
Signos oculares de la xeroftalmia
• Variación de la puntuación de hiperemia (escala de McMonnies – Chapman) entre el D0 y el D14, y entre el D28 y el D84.
• Variación de la puntuación TBUT entre el D0 y el D14, y entre el D28 y el D84.
• Variación de la tinción corneal y conjuntival con fluoresceína (escala de graduación de Oxford) entre el D0 y el D14, y entre el D28 y el D84.
• Variación de la tinción corneal y conjuntival con verde de lisamina (escala de Van Bijsterveld) entre el D0 y el D14, y entre el D28 y el D84.
• Variación del valor de la altura del menisco lagrimal entre el D0 y el D14, y entre el D28 y el D84.
• Variación de los resultados de la prueba de Schirmer I entre el D0 y el D14, y entre el D28 y el D84.
Signos oculares de la MGD
• Variación de la graduación de la MGD según una graduación de 0 a 4, donde el 0 es la ausencia de prolapso de la glándula de Meibomio y una secreción de meibum de aspecto claro y el 4 representa la presencia de prolapso de la glándula de más de la mitad del borde palpebral o queratinización completa de los conductos y ausencia de secreción de meibum.
• Variación de la puntuación de anomalías palpebrales (irregularidad, espesor y obstrucción) según una graduación de 0 a 2, donde el 0 es la ausencia de hallazgos y el 2 es la presencia de hallazgos graves.
• Variación de la puntuación de telangiectasia palpebral según una graduación de 0 a 3, donde el 0 es la ausencia de hallazgos y el 3 es la presencia de hallazgos graves, entre el D0 y el D14, y entre el D28 y el D84.
• Variación de la puntuación de la tinción con verde de lisamina del borde palpebral entre el D0 y el D14, y entre el D28 y el D84.
• Variación de la capacidad de secreción de la glándula de Meibomio entre el D0 y el D14, y entre el D28 y el D84.
Citocinas inflamatorias
• Variación entre el valor del D0 y el D14 (ambos ojos) de la concentración de las siguientes citocinas inflamatorias en las lágrimas: IL-6, TNF alfa, IL-1b, IL-10, IFNγ, IL-17A, IL-2, IL-4. El primer ojo del que se obtenga la muestra será el ojo del estudio.
Seguridad:
Criterios de valoración secundarios de la seguridad
• Incidencia de los acontecimientos adversos (AA) y acontecimientos adversos graves (AAG) durante el estudio.
• Variación de la agudeza visual entre el D0, el D14, el D28 y el D84. Se utilizará la escala ETDRS (Early Treatment Diabetic Retinopathy Study).

E.5.2.1

Timepoint(s) of evaluation of this end point

For all secundary endpoints: from day 1 to day 84.

Para todas las variables secundarias desde el día 1 al 84.

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Grupo de control sin Softacort

Control group without treatment of Softacort

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

LPLV

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

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)

According clinical practice.

Acorde a la práctica clínica.

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

2021-09-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-14

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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