Clinical Trials Register

Summary
EudraCT Number:	2012-002078-30
Sponsor's Protocol Code Number:	RDG-11-244
National Competent Authority:	Slovenia - JAZMP
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-01-07
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Slovenia - JAZMP

A.2

EudraCT number

2012-002078-30

A.3

Full title of the trial

Assessing the Efficacy and Tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative (travoprost 0.004%) versus LUMIGAN® 0.01% Solution with BAK (bimatoprost 0.01%) in Treatment Naïve patients with Ocular Hypertension or Open Angle Glaucoma

A.3.1

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

Comparison of efficacy and tolerability of Travatan and Lumigan in patients with ocular hypertension or glaucoma but who never received any glaucoma drugs.

A.4.1

Sponsor's protocol code number

RDG-11-244

A.5.4

Other Identifiers

Name:

Not available

Number:

Not available

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	Dokumeds Ltd
B.5.2	Functional name of contact point	Rasa Ziliuviene
B.5.3	Address:
B.5.3.1	Street Address	Alojas 6
B.5.3.2	Town/ city	Riga
B.5.3.3	Post code	LV-1013
B.5.3.4	Country	Latvia
B.5.4	Telephone number	37052101449
B.5.5	Fax number	37052101450
B.5.6	E-mail	Rasa.Ziliuviene@Dokumeds.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	TRAVATAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Alcon Laboratories (UK) Ltd.
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, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	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	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	LUMIGAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergan Pharmaceuticals Ireland
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	LUMIGAN
D.3.4	Pharmaceutical form	Eye drops, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BIMATOPROST
D.3.9.1	CAS number	155206-00-1
D.3.9.4	EV Substance Code	SUB12470MIG
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	0.1
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.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

Ocular hypertension or Open angle glaucoma

E.1.1.1

Medical condition in easily understood language

Ocular hypertension and glaucoma.

E.1.1.2

Therapeutic area

Body processes [G] - Ocular Physiological Phenomena [G14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	HLGT
E.1.2	Classification code	10018307
E.1.2	Term	Glaucoma and ocular hypertension
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 objective of this study is to assess the efficacy and tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative versus LUMIGAN® 0.01% Solution in treatment naïve patients with ocular hypertension or open angle glaucoma.

E.2.2

Secondary objectives of the trial

For the secondary analysis, changes in the following study variables will be assessed: Ocular Hyperemia grading, Tear Film Break Up Time, Ocular Surface Disease Index (OSDI), Ocular Staining (before and after 6 months of PGA therapy) and the percentage of patients who reach target IOP (≤18 mmHg) after 6 months of PGA therapy. The following exploratory variables will also be evaluated: Assessing both conjunctival epitheliai cells and goblet cells in impression cytology specimens before and after 6 months of PGA therapy and Assessing the expression of both HLA-DR (an inflammatory marker) and MUC5AC (a protein found in goblet cells) in impression cytology specimens by flow cytometry before and after 6 months of PGA therapy.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Must be at least 18 years of age.
2. Must be diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
3. Must have an IOP between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
4. Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
5. Must have a baseline a tear film break up time (TBUT) of ≥ 5 seconds.
6. Must have a baseline ocular staining grade of < III (i.e. between 0 and II) based on Oxford scale.
7. In case one eye is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
8. Must be able to follow instructions and be willing and able to attend all study visits.
9. Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
10. An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.

E.4

Principal exclusion criteria

1. Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
2. Any abnormality preventing reliable applanation tonometry in either eye.
3. Corneal dystrophies in either eye.
4. Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
5. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
6. History of severe dry eye, keratoconjunctivitis sicca, ocular pemphigoid or Stevens-Johnson syndrome.
7. Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
8. History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications)
9. Contact lens wearers are excluded
10. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
11. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
12. Progressive retinal or optic nerve disease from any cause.
13. A history of, or at risk for uveitis or cystoid macular edema (CME).
14. Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
15. Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
16. Women who are pregnant or lactating
17. Unwillingness to risk the possibility of darkened iris or eyelash changes.
18. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
19. Participation in any other investigational study within 30 days prior to the Screening Visit.

E.5 End points

E.5.1

Primary end point(s)

Mean Change in IOP from baseline between both treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

Month 3 and Month 6 visits.

E.5.2

Secondary end point(s)

Change in Ocular Hyperemia grading after 6 months of PGA therapy between both treatment groups; Change in Ocular Surface Disease Index after 6 months of PGA therapy between both treatment groups; Change in tear film break up time (after 6 months of PGA therapy) between both treatment groups; Change in ocular staining (after 6 months of PGA therapy) between both treatment groups Percentage of patients who reach target IOP (≤ 18 mmHg) between both treatment groups. An interim analysis of all study variables will be conducted at the 3 month visit.

E.5.2.1

Timepoint(s) of evaluation of this end point

Month 3 and Month 6 visits.

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

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

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

LVLS

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:

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

104

F.4.2

For a multinational trial

F.4.2.1

In the EEA

104

F.4.2.2

In the whole clinical trial

104

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)

Standard therapy, no differences from the normal treatment

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

2012-09-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-06-18

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials