Clinical Trials Register

Summary
EudraCT Number:	2012-003007-35
Sponsor's Protocol Code Number:	192024-046
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-12-11
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2012-003007-35

A.3

Full title of the trial

Bimatoprost in the Treatment of Eyelash Hypotrichosis

A.3.1

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

Treatment of subjects with inadequate or not enough eyelashes

A.4.1

Sponsor's protocol code number

192024-046

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01698554

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	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	Allergan Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Allergan Limited
B.5.2	Functional name of contact point	Allergan Limited EU Regulatory Dept
B.5.3	Address:
B.5.3.1	Street Address	1st Floor Marlow International, The Parkway
B.5.3.2	Town/ city	Marlow, Buckinghamshire
B.5.3.3	Post code	SL7 1YL
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441628494444
B.5.5	Fax number	+441628494449
B.5.6	E-mail	ml-eu_reg_affairs@allergan.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	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 solution 0.03% in a single-dose vial
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
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	0.3
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	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	LATISSE®
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergan Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
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	0.3
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cutaneous solution
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cutaneous solution
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Eyelash Hypotrichosis

E.1.1.1

Medical condition in easily understood language

Inadequate or not enough eyelashes

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10021127
E.1.2	Term	Hypotrichosis of eyelid
E.1.2	System Organ Class	100000004858

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 evaluate the safety and efficacy of bimatoprost solution 0.03% single dose vial configuration compared with marketed bimatoprost solution 0.03% in the bottle/applicator configuration and vehicle in increasing overall eyelash prominence following once daily, bilateral, dermal administration to the upper eyelid margins of patients with idiopathic eyelash hypotrichosis.

E.2.2

Secondary objectives of the trial

None

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, 18 years of age or older
2. Patient has eyelash hypotrichosis as measured by a GEA score of 1 or 2 at screening and baseline
5. Visual acuity score equivalent to a Snellen acuity of 20/100 or better in each eye, using a standardized logarithmic visual acuity chart for testing at 10 feet and wearing any prescribed spectacles or contact lens
6. Standardized eyelash photographs during the screening period of acceptable quality for image analysis as verified by Canfield Scientific, Inc (Fairfield, NJ)
7. Ability to follow study instructions and likely to complete all required visits
8. For females of childbearing potential, a negative pregnancy test result must be confirmed prior to receiving study treatment on day 1. A woman is considered NOT to be of childbearing potential if she either is postmenopausal with at least 12 consecutive months of amenorrhea or has no uterus.
9. Patient has the ability to follow study instructions and complete study assessment tools, (eg, ESQ-9) without any assistance or alteration to the assessment tool

E.4

Principal exclusion criteria

1. Uncontrolled systemic disease
2. Significant asymmetry of eyelashes of the right and left eyelid, based on the opinion of the investigator
3. Any clinically significant condition or abnormality of the lashes, ocular surface, periocular skin, or lacrimal duct system
4. Any damage to the eyelid area (eg, scarring) that may prevent the growth of eyelashes
5. Known or suspected trichotillomania disorder
6. Any ocular pathology in either eye that may interfere with the ability to obtain accurate IOP readings
7. Contraindications to pupil dilation
8. Active ocular disease (eg, glaucoma, uveitis, ocular infections, chronic blepharitis, or severe dry eye). However, myopia, strabismus, and cataracts are allowed, provided other study criteria are met
9. Any ocular or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening or any anticipated need for ocular surgery for the duration of the study
10. Patients unwilling or unable to remove contact lenses prior to application of study treatment in the evening and keep lenses out for at least 15 minutes following application
11. Any permanent eyeliner on the upper eyelid margin
12. Current eyelash implants of any kind, or anticipated use of false eyelashes during the study
13. Any eyelash tint or dye application within 2 months of baseline
14. Any eyelash extension application within 3 months of baseline 15. Any use of eyelash growth products within 6 months of baseline
16. Any history of use of prescription eyelash growth products (eg, LATISSE)
17. Concurrent treatment with any prostaglandin or prostamide (ocular or systemic)
18. Treatments that may affect hair growth (eg, minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline, or anticipated use of these treatments during the study
19. Any patients requiring IOP-lowering eye medication or requiring prescription medications for dry eye at baseline, or anticipated use of these treatments during the study
20. Patients with macular edema or those who are aphakic, pseudophakic with a torn posterior lens capsule, or patients having known risk factors for macular edema
21. Known allergy or sensitivity to the study treatment(s) or its components or the eye makeup remover provided in the study
22. Females who are pregnant, nursing, or planning a pregnancy
23. Females of childbearing potential, not using a reliable means of contraception as determined between the patient and investigator
24. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and previous enrollment in any Allergan sponsored bimatoprost studies
25. Investigational site staff and/or their relatives
26. Patient has a condition or is in a situation which 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

E.5 End points

E.5.1

Primary end point(s)

The proportion of patients with at least a 1-grade increase (improvement) from baseline in the GEA score at month 4.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline and month 4

E.5.2

Secondary end point(s)

Change from baseline at month 4 in eyelash length as measured using DIA.

Change from baseline at month 4 in eyelash thickness/fullness as measured using DIA.

Change from baseline at month 4 in eyelash darkness as measured using DIA.

Proportion of patients who report “very satisfied/satisfied” or "neutral/unsatisfied/very unsatisfied” in Item #3 from ESQ-9 at month 4.

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline and month 4

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

Yes

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

Russian Federation

Sweden

United Kingdom

United States

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:

434

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

454

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)

None

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

2012-12-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-03-17

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