Clinical Trials Register

Summary
EudraCT Number:	2009-010604-29
Sponsor's Protocol Code Number:	C-09-007
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2009-05-07
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2009-010604-29

A.3

Full title of the trial

An evaluation of the Ocular Surface Health in Subjects Using DuoTrav APS Eye Drops Solution Versus XALACOM® EYE Drops Solution

A.4.1

Sponsor's protocol code number

C-09-007

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point
B.Sponsor: 2
B.1.1	Name of Sponsor	Alcon Hungary Ltd.
B.1.3.4	Country	Hungary
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	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	DuoTrav APS
D.3.4	Pharmaceutical form	Eye drops, solution
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Ocular use Topical use (Noncurrent)
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.3.9.2	Current sponsor code	AL-6221
D.3.9.3	Other descriptive name	TRAVOPROST
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIMOLOL MALEATE
D.3.9.1	CAS number	26921175
D.3.9.2	Current sponsor code	AL-1239
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	6.8 to (5 mg/ml timolol)
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Xalacom (Xalcom)
D.2.1.1.2	Name of the Marketing Authorisation holder	Pharmacia Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Eye drops, solution
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Ocular use Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LATANOPROST
D.3.9.1	CAS number	130209824
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIMOLOL MALEATE
D.3.9.1	CAS number	26921175
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	6.8 to (5 mg/ml timolol)
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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/dry eye

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10030348
E.1.2	Term	Open angle glaucoma

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	HLGT
E.1.2	Classification code	10018307
E.1.2	Term	Glaucoma and ocular hypertension

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10030043
E.1.2	Term	Ocular hypertension

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10013774
E.1.2	Term	Dry eye

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

to demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Disease Index (OSDI) scores in patients with open-angle glaucoma or ocular hypertension.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients ≥ 18 years of age.
2. Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye.
3. Ocular Surface Disease Index (OSDI) score of ≥ 13.
4. Must have a corneal fluorescein staining score of ≥ 1 in at least one eye
5. Must have had their IOP controlled using only the fixed combination XALACOM® for at least 1 continuous month immediately prior to Visit 1 in at least one eye.
6. The intraocular pressure should be able to be controlled in the opinion of the investigator and stable while on fixed combination with the study medication for the eye(s) currently being dosed with XALACOM®.
7. Must have an intraocular pressure in both eyes that, in the opinion of the investigator, is considered to be stable and safe for the patient.
8. The last dose of XALACOM® must have been instilled within 24 hours of Visit 1.
9. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
10. Best-corrected visual acuity score of ≥ 55 ETDRS letters read in each eye
11.Women of childbearing potential must meet all of the following conditions at Visit 1:
• They are not breast-feeding.
• They have a negative urine pregnancy test at Visit 1.
• They agree to undertake a urine pregnancy test upon entering and exiting the study.
• They are not planning to become pregnant during the course of the study.
• They are currently using, and agree to continue to use adequate birth control methods for the duration of the study. Adequate birth control methods are defined as:
Hormonal: oral, implantable, topical, or injectable contraceptives
Mechanical: IUD, spermicide in conjunction with a barrier such as condom or diaphragm
Surgical: sterilization of partner and / or self
Abstinence: If patients become sexually active, they must agree to use one of the birth
control methods (hormonal, mechanical, or surgical) listed above.

E.4

Principal exclusion criteria

1. Any abnormality preventing reliable applanation tonometry in the study eye(s).
2. Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the investigator may preclude the safe administration of test article or safe participation in this study.
3. Dry eye or KCS which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
4. Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 1 year prior to Visit 1.
5. Any other ocular laser surgery in either eye within 3 months prior to Visit 1.
6. Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
7. History of progressive retinal or optic nerve disease other than glaucoma.
8. Severe central visual field loss in either eye based upon the clinical judgment of the investigator.
9. Any history of, or current evidence of, infectious or inflammatory ocular conditions, such as clinically significant blepharitis in the past 2 years, rosacea affecting the eye adnexa and its ocular sequelae (e.g., hordeola, chalazion, recurrent meibomian gland dysfunction), clinically significant corneal dystrophies, recurrent inflammatory eye diseases (e.g., uveitis, scleritis, herpes keratitis, iritis, etc), ocular allergies known to occur during the season in which the patient is enrolled in this study.
10. Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination.
11. History or evidence of corneal transplant or transplant variant procedures [Descemet’s stripping endothelial keratoplasty (DSEK), Descemet’s stripping endothelial automated keratoplasty (DSAEK), lamellar keratoplasty, etc.].
12. Patients with suspected or diagnosed Sjogren’s syndrome.
13. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent.
14. History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease (e.g., sinus bradycardia, overt cardiac failure, greater than first degree
atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled
hypertension) that would preclude the safe administration of a topical beta-adrenergic blocking agent.
15. History of spontaneous or current hypoglycemia or uncontrolled diabetes.
16. History of or current severe allergic rhinitis and bronchial hyper reactivity.
17. History of intolerance or hypersensitivity to any component of the test articles.
18. Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
19. Use of ocular medications (including over the counter and prescription medications) other than XALACOM® within 7 days of Visit 1.
20. Use of corticosteroids within 30 days of Visit 1, or any anticipated use of corticosteroids during the course of the study.
21. Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
22. Participation in an investigational drug or device study within 30 days of entering this study.

E.5 End points

E.5.1

Primary end point(s)

Mean change from baseline (Day 0) in Ocular Surface Disease Index (OSDI) score at the end of the treatment period (Day 90).

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.8.3

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.8.5

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

Information not present in EudraCT

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

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

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	40
F.4.2	For a multinational trial
F.4.2.1	In the EEA	330
F.4.2.2	In the whole clinical trial	700

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

2009-08-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-06-03

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2011-02-21

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