Clinical Trials Register

Summary
EudraCT Number:	2010-021507-24
Sponsor's Protocol Code Number:	192024-050
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-09-20
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

2010-021507-24

A.3

Full title of the trial

A Multicenter, Double-masked, Randomized, Parallel Study of the Safety and Efficacy
of Bimatoprost 0.03%/Timolol 0.5% Preservative-free Ophthalmic Solution Compared
with GANFORT® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) Once Daily
for 12 Weeks in Patients with Glaucoma or Ocular Hypertension

A.4.1

Sponsor's protocol code number

192024-050

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	Allergan Limited
B.1.3.4	Country	United Kingdom
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	Bimatoprost 0.03%/Timolol 0.5% PF Ophthalmic Solution
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
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.3.9.2	Current sponsor code	AGN-192024
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	0.3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIMOLOL
D.3.9.1	CAS number	26839-75-8
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	5
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	GANFORT®
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.3.4	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
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.3.9.2	Current sponsor code	AGN-192024
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	0.3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIMOLOL
D.3.9.1	CAS number	26839-75-8
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	5
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 or Ocular Hypertension

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
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	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10008833
E.1.2	Term	Chronic angle-closure glaucoma

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10009034
E.1.2	Term	Chronic open angle glaucoma

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 compare the efficacy and safety of bimatoprost 0.03%/ timolol 0.5% PF ophthalmic
solution with GANFORT once-daily use for 12 weeks in patients with glaucoma or ocular hypertension (OHT).
To show that bimatoprost 0.03%/timolol 0.5% PF ophthalmic solution has an acceptable safety profile.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, 18 years of age or older and with legal age of consent.
2. Written informed consent has been obtained.
3. Written data protection consent has been obtained.
4. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
5. Good general health, as determined by the investigator from medical history, physical examination finding, fasting blood analysis (hematology, blood chemistry), and urinalysis, that are within reference range or acceptable to the investigator. Patients may have laboratory tests repeated once for re-screening at the discretion of the investigator.
6. Baseline: A negative urine pregnancy test result for females of childbearing potential. A female is considered to be of non-childbearing potential if she is postmenopausal (with no menses for 12 consecutive months) or without a uterus.
7. Patient is able and willing to follow study instructions and likely to complete all
required visits.
8. Patient has ocular hypertension, chronic open-angle glaucoma, chronic-angle closure glaucoma with patent iridotomy/iridectomy, pseudoexfoliative glaucoma, or
pigmentary glaucoma in both eyes.
9. Patient can go without IOP-lowering therapy for 4 days to 4 weeks, without
significant risk to the patient.
10. Patient requires bilateral IOP-lowering therapy
11. Hour 0 of screening: Patient has been on current medication for at least 1 month or is treatment naive.
12. Hour 0 and hour 2 of screening: Approximately 12 to 14 hours after the last
installation of any current medication, patient had been on treatment considered to be ineffective (IOP > 18 mm Hg in at least 1 eye) for at least 1 month OR treatment
naive (IOP > 24 mm Hg in at least 1 eye). Qualifying hour 0 and hour 2 IOPs must
have been from the same eye.
13. Hour 0 of baseline: best-corrected visual acuity (BCVA) score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart.
14. Hour 0 of baseline: IOP of ≥ 22 mm Hg and ≤ 30 mm Hg in each eye and asymmetry
of IOP not greater than 3 mm Hg between the eyes

E.4

Principal exclusion criteria

1. Uncontrolled systemic disease.
2. Female patients who are pregnant, nursing, or planning a pregnancy or who are of
childbearing potential and not using a reliable means of contraception throughout the study.
3. Clinically relevant low or high blood pressure or pulse rate for age as determined by the investigator.
4. Patient has a condition or is in a situation that, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere
significantly with the patient’s participation in the study.
5. Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure or cardiogenic shock or uncontrolled congestive heart failure.
6. Known allergy or contraindication to use of fluorescein.
7. Known allergy or sensitivity to the study medications or their components.
8. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days prior to baseline or anticipated use within 21 days prior to a follow-up study visit, or topical ophthalmic corticosteroids from 2 months prior to the screening visit through the final study visit.
9. Current enrollment in an investigational drug or device study or participation in such a study at or past the screening visit, or within 30 days prior to the baseline/day -1 visit.
10. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer (eg, refractive surgery, corneal graft, moderate to severe endothelial corneal dystrophy).
11. Contraindication to pupil dilation.
12. Central corneal thickness of greater than 600 micrometers or less than 500 micrometers in either eye at screening.
13. Introduction or anticipated alteration of existing chronic systemic medications
(topical or injection) that may have a substantial effect on IOP (eg, systemic betablockers) from 2 months prior to screening visit through the final study visit.
14. Active or recurrent ocular disease (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies) that would interfere with the interpretation of the study data in either eye. NOTE: patients with chronic mild blepharitis, cataract, age-related macular degeneration, or a background diabetic retinopathy can be enrolled at the discretion of the investigator.
15. History (within 6 months prior to baseline) of any ocular anterior segment laser or
other intraocular surgery in either eye.
16. History or evidence of severe ocular trauma in either eye.
17. History of ocular neoplasia, uveitis, or herpetic ocular diseases.
18. Required chronic use of other ocular medications (post-screening visit) during the
study. NOTE: occasional use of artificial tear products is allowed but not within
24 hours prior to a scheduled visit.
19. Visual field loss that in the opinion of the investigator is functionally significant, or
evidence of progressive visual field loss within the year prior to baseline (day -1).
20. In either eye, anticipated wearing of contact lenses during the study (use of soft lenses should be discontinued at least 24 hours prior to baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to baseline).
21. Patient’s IOP was previously uncontrolled on bimatoprost monotherapy.
22. Hour 0 of baseline : Ocular surface findings (eg, hyperemia or irritation equal to +0.5 [trace] or greater) in either eye.

E.5 End points

E.5.1

Primary end point(s)

The IOP-lowering effect of bimatoprost 0.03%/timolol 0.5% PF ophthalmic solution is non inferior to GANFORT.

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)

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.8.4.1

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

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

Last patient visit

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	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	50
F.4.2	For a multinational trial
F.4.2.1	In the EEA	450
F.4.2.2	In the whole clinical trial	500

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

2010-11-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-10-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-02-20

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