Clinical Trials Register

Summary
EudraCT Number:	2011-004587-29
Sponsor's Protocol Code Number:	C-11-034
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:	2012-01-11
Trial results	View 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

2011-004587-29

A.3

Full title of the trial

A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients with Open-Angle Glaucoma or Ocular Hypertension

Estudio multicéntrico doble enmascarado sobre la seguridad y la eficacia de Travoprost solución oftálmica 0,003% en comparación con TRAVATAN en pacientes con glaucoma de ángulo abierto o hipertensión ocular

A.3.1

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

A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients with Open-Angle Glaucoma or Ocular Hypertension

A.3.2

Name or abbreviated title of the trial where available

A Multicenter, Double-Masked Study of the Safety and Efficacy of 30 µg/mL Travoprost

Estudio multicéntrico doble enmascarado sobre la seguridad y la eficacia de Travoprost 30 µg/mL

A.4.1

Sponsor's protocol code number

C-11-034

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01453855

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	Alcon Research Ltd.
B.1.3.4	Country	United States
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	Alcon Research Ltd.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	N.V. Alcon Couvreur S.A.
B.5.2	Functional name of contact point	Inez Carels, Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Rijksweg 14
B.5.3.2	Town/ city	Puurs
B.5.3.3	Post code	2870
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+32 38902820
B.5.5	Fax number	+32 38902825
B.5.6	E-mail	Inez.Carels@alconlabs.com

D. IMP Identification
D.IMP: 1
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	TRAVATAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Alcon Laboratories
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Travatan
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	Travoprost
D.3.9.1	CAS number	157283-68-6
D.3.9.3	Other descriptive name	TRAVOPROST
D.3.9.4	EV Substance Code	SUB12613MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.004
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	No
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	Travoprost 0.003% Eye Drops
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	Travoprost
D.3.9.1	CAS number	157283-68-6
D.3.9.3	Other descriptive name	TRAVOPROST
D.3.9.4	EV Substance Code	SUB12613MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.003
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

Glaucoma; elevated Intraocular Pressure (IOP)

Glaucoma; Presión intraocular elevada (PIO)

E.1.1.1

Medical condition in easily understood language

Glaucoma; Elevated IOP

Glaucoma; PIO elevada

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10018304
E.1.2	Term	Glaucoma
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

The primary objective of this study is to demonstrate that the IOP lowering efficacy of Travoprost Ophthalmic Solution, 0.003% is equivalent to TRAVATAN® in patients with open-angle glaucoma or ocular hypertension.

El objetivo principal de este estudio es demostrar que la eficacia de Travoprost solución oftálmica 0,003% para disminuir la presión intraocular es equivalente a la de TRAVATAN® en pacientes con glaucoma de ángulo abierto o hipertensión ocular.

E.2.2

Secondary objectives of the trial

N.A.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?Inclusion Criteria:
1. Patients 18 years of age or older
2. Diagnosis of open-angle glaucoma (including open-angle
glaucoma with pseudoexfoliation or pigment dispersion)
or ocular hypertension.
3. Qualifying mean IOP (after washout) at both the
Eligibility 1 and 2 Visits in at least 1 eye (the same eye)
must be:
? ? 24 mmHg at the 8 AM (± 30 minutes) time point
and,
? ? 21 mmHg at the 10 AM (± 30 minutes) and 4 PM
(± 30 minutes) time points.
Mean IOP must be ? 36 mmHg at all time points, OU.
Note: Mean IOP is the average of 2 successive IOP
measurements in the same eye, as described in the Manual
of Procedures. A third measurement is required if the first
2 measurements differ by more than 4 mmHg.
4. Must be able to understand and sign an informed consent
form that has been approved by an Institutional Review
Board/Independent Ethics Committee.

Criterios de inclusión:
1.Pacientes de 18 años de edad o más
2. Diagnóstico de glaucoma de ángulo abierto (incluido glaucoma de ángulo abierto con pseudoexfoliación o dispersión del pigmento) o hipertensión ocular.
3. La PIO media habilitante (después del periodo de lavado) en las Visitas de elegibilidad 1 y 2 debe ser la siguiente en al menos 1 ojo (el mismo ojo):
? ? 24 mmHg a las 8 horas (± 30 minutos)
y
? ? 21 mmHg a las 10 horas (± 30 minutos) y a las 16 horas (± 30 minutos).
La PIO media debe ser ? 36 mmHg en todos los momentos de medición, OU.
Nota: La PIO media es el promedio de 2 mediciones consecutivas de la PIO en el mismo ojo, según el Manual de procedimientos. Se requiere una tercera medición si hay una diferencia mayor de 4 mmHg entre las 2 primeras mediciones.
4. Los pacientes deben entender y firmar un formulario de consentimiento informado aprobado por un Junta de Revisión Institucional/Comité Ético Independiente.

E.4

Principal exclusion criteria

?1. Women of childbearing potential (ie, those who are not postmenopausal for at least 1 year or surgically sterile) are ?excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy
throughout the study.

?Related to disease/condition being investigated (either eye)
2. Modified Shaffer angle grade < 2 as measured by
gonioscopy (extreme narrow angle with complete or
partial closure).
3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
vertical measurement).
4. Severe central visual field loss defined as a sensitivity
? 10 dB in at least 2 of the 4 visual field test points closest
to the point of fixation.
5. Patients who in the opinion of the Investigator cannot
discontinue all IOP-lowering ocular medication(s) per the
appropriate washout schedule prior to the E1 Visit.

Related to previous or current ocular disease/condition
(either eye)
6. History of chronic, recurrent or severe inflammatory eye
disease (ie, scleritis, uveitis, herpes keratitis).
7. Ocular trauma requiring medical attention within the past
6 months prior to the Screening Visit.
8. Ocular infection or ocular inflammation within the past
3 months prior to the Screening Visit.
9. Clinically significant or progressive retinal disease such as
retinal degeneration, diabetic retinopathy, or retinal
detachment.
10. Best-corrected visual acuity (BCVA) score worse than
55 ETDRS letters (equivalent to approximately 0.60
logMAR, 20/80 Snellen, or 0.25 decimal).
11. Other severe ocular pathology (including severe dry eye),
in the opinion of the Investigator, that would preclude the
administration of a topical prostaglandin analog.
12. Intraocular surgery within the past 6 months prior to the
Screening Visit.
13. Ocular laser surgery within the past 3 months prior to the
Screening Visit.
14. Any abnormality preventing reliable applanation tonometry.

1. Las mujeres en edad fértil (es decir, que no hayan sido posmenopáusicas durante al menos 1 año o que no sean quirúrgicamente estériles) no pueden participar si están embarazadas, si tienen un resultado positivo en la prueba de embarazo en orina durante la Selección o si piensan quedar embarazadas durante el período del estudio, si están lactando o si no aceptan usar métodos anticonceptivos adecuados para prevenir el embarazo a lo largo del estudio.

Respecto de la enfermedad/afección bajo investigación (cualquiera de los ojos)
2. Ángulo de Shaffer modificado, grado < 2 medido por gonioscopía (ángulo extremadamente estrecho con cierre completo o parcial).
3. Relación del área de excavación y el disco (C/D) mayor de 0,80 (medición horizontal o vertical).
4. Pérdida grave del campo visual central, definida como una sensibilidad ? 10 dB en al menos 2 de los 4 puntos de la prueba de campo visual más cercanos al punto de fijación.
5. Pacientes que, a criterio del Investigador, no pueden suspender todos los medicamentos para disminuir la PIO según el cronograma de periodo de lavado apropiado antes de la Visita E1.

Respecto de enfermedades/afecciones oculares previas o actuales (cualquiera de los ojos)
6. Historia de enfermedad ocular inflamatoria crónica, recurrente o intensa (es decir, escleritis, uveítis, queratitis herpética).
7. Trauma ocular que haya requerido atención médica durante los 6 meses previos a la Visita de selección.
8. Infección ocular o inflamación ocular durante los 3 meses previos a la Visita de selección.
9. Enfermedad clínicamente significativa o progresiva de la retina, como degeneración de la retina, retinopatía diabética o desprendimiento de la retina.
10. Puntuación de agudeza visual mejor corregida (BCVA) peor que 55 letras ETDRS (equivalente a aproximadamente 0,60 logMAR, 20/80 Snellen ó 0,25 decimal).
11. Otra patología ocular grave (incluido ojo seco grave) que a criterio del Investigador impediría la administración de un análogo de prostaglandina tópico.
12. Cirugía intraocular durante los 6 meses previos a la Visita de selección.
13. Cirugía ocular láser durante los 3 meses previos a la Visita de selección.
14. Cualquier anormalidad que impida una tonometría de aplanación fiable.

E.5 End points

E.5.1

Primary end point(s)

?Primary Efficacy
? IOP at Week 2, Week 6, and Month 3 for each time point (8 AM, 10 AM and 4 PM)

Eficacia primaria
?PIO la Semana 2, la Semana 6 y el Mes 3 para cada punto temporal (8 horas, 10 horas y 16 horas)

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 2, Week 6, and Month 3 for each time point (8 AM, 10 AM and 4 PM)

La Semana 2, la Semana 6 y el Mes 3 para cada punto temporal (8 horas, 10 horas y 16 horas)

E.5.2

Secondary end point(s)

?? IOP change from baseline and IOP percent change from baseline at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).
? Percentage of patients who achieve a target IOP level < 18 mmHg at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).

?Proportion of patients who achieve IOP lowering of at least 30% from baseline at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).

?Cambio de PIO respecto el basal y cambio porcentual de la PIO respecto el basal en cada visita (Semana 2, Semana 6 y Mes 3) y punto temporal (8 horas, 10 horas y 16 horas).

?Porcentaje de pacientes que logran un nivel de PIO diana de <18 mmHg en cada visita (Semana 2, Semana 6 y Mes 3) y punto temporal (8 horas, 10 horas y 16 horas).

?Proporción de pacientes que lograron una reducción de la PIO de al menos un 30%, a partir del valor basal en cada visita (semana 2, semana 6 y mes 3) y punto temporal(08:00, 10:00 y 16:00 horas).

E.5.2.1

Timepoint(s) of evaluation of this end point

at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).

Para cada visita (Semana 2, Semana 6 y Mes 3) y para cada punto temporal (8 horas, 10 horas y 16 horas)

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Belgium

Germany

Hungary

Israel

Italy

Mexico

Netherlands

Spain

Sweden

United Kingdom

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last Patient Last Visit is defined as the end of the trial.

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

360

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

360

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

500

F.4.2.2

In the whole clinical trial

720

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)

Subjects will be provided treatment in accordance with the current standard of care.

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

2012-02-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-15

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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