Clinical Trials Register

Summary
EudraCT Number:	2017-000846-23
Sponsor's Protocol Code Number:	LT4032-301
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-07-02
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

France - ANSM

A.2

EudraCT number

2017-000846-23

A.3

Full title of the trial

Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.

A.3.1

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

Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.

A.3.2

Name or abbreviated title of the trial where available

In-SIGHT study

A.4.1

Sponsor's protocol code number

LT4032-301

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	Laboratoires THEA
B.1.3.4	Country	France
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	Laboratoires THEA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Laboratoires THEA
B.5.2	Functional name of contact point	Clinical department
B.5.3	Address:
B.5.3.1	Street Address	12, rue Louis Blériot
B.5.3.2	Town/ city	Clermont-Ferrand cedex 2
B.5.3.3	Post code	F-63017
B.5.3.4	Country	France
B.5.4	Telephone number	+ 33 4 73 98 14 36
B.5.5	Fax number	+ 33 4 73 98 14 24
B.5.6	E-mail	Aude.BARDIOT@theapharma.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
D.3.2	Product code	T4032
D.3.4	Pharmaceutical form	Eye gel in single-dose container
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.3.9.2	Current sponsor code	T4032
D.3.9.4	EV Substance Code	SUB12470MIG
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	0.01
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	Lumigan® 0.01 %
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	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	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.01
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: 3
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	Azopt®
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
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, ocular hypertension

E.1.1.1

Medical condition in easily understood language

over tension in the eye

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	20.0
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

To demonstrate the non-inferiority of T4032 unpreserved eye drops compared to Lumigan® 0.01% in terms of efficacy.

E.2.2

Secondary objectives of the trial

To evaluate the safety and efficacy of T4032 versus Lumigan® 0.01%.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

At Screening Visit (D-42):
-Informed consent signed and dated.
-Patient aged ≥18 years old.
-Both eyes with 500 µm ≤ central corneal thickness ≤ 600 µm.
-Both eyes with diagnosed open-angle glaucoma or ocular hypertension, initially treated and controlled (including IOP ≤ 18 mmHg) for at least 6 months by any prostaglandin monotherapy.
-Both eyes with IOP ≤ 18 mmHg.

At Randomisation Visit (D1) at 8:00:
-Both eyes with 22 mmHg ≤ IOP < 34 mmHg and with asymmetry between eyes ≤ 3 mmHg.

E.4

Principal exclusion criteria

Ophthalmic Exclusion Criteria in AT LEAST ONE EYE:
-Fundus examination not performed or not available within 12
months.
-Visual field not performed or not available within 12 months.
- Significant worsening according to the two last visual fields (at
least 6 months between the two visual fields).
-Advance stage of glaucoma, defined by at least one of the following criteria:
- Absolute defect in the ten degrees central point of the visual field.
- Severe visual field loss: MD < -18 dB.
-Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement.
-History of non-responder to bimatoprost therapy.
-Far Best Corrected Visual Acuity ≥ + 0.7 Log Mar (e.g., ≤ 0.2 in decimal value or ≤ 20/100 Snellen equivalent or ≤ 50 ETDRS letters).
-History of trauma, infection, clinically significant inflammation
within the 3 previous months.
-Ongoing or known history of ocular allergy and/or uveitis
and/or viral infection.
-Clinically significant or progressive retinal disease (e.g. retinal
degeneration, diabetic retinopathy, retinal detachment).
-Presence of at least one severe objective sign among the following:
-Conjunctival hyperaemia (Grade 5 / McMonnies
scale).
-Superficial punctate keratitis (Grade 4/5 / Oxford
scale).
- Blepharitis (Grade 3 / 0-3 scale).
- Severe dry eye as assessed by the investigator.
- Corneal ulceration.
-Any palpebral abnormality incompatible with a good
examination.
-Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination.

Regarding Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions and Exclusion Criteria Related to Previous and Concomitant Treatments (Medications/Non-Medicinal Therapies/Procedures) please refer to the study protocol in page 28.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline (Day 1) to Week 12 in IOP at the three time points (8:00 am; 10:00 am; 4:00 pm) in the worse eye.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 timepoints (8:00 am; 10:00 am; 4:00 pm) at Visit#2 (Day 1), Visit 3 (week 6) and visit 4 (week 12)

E.5.2

Secondary end point(s)

Efficacy secondary Endpoints:
Change from baseline to Week 12 in IOP at the three time points (8:00, 10:00 and 16:00) in the contralateral eye.
Others efficacy endpoints will be analysed:
- Change from baseline to Week 6 in IOP at the three time points (8:00; 10:00; 16:00) in the worse eye and in the contralateral eye.
- Efficacy assessed by the investigator.

Safety Endpoints:
-Conjunctival hyperaemia on McMonnies scale at Week 6 and Week 12.
-Change from baseline of the conjunctival hyperaemia on McMonnies scale in 3 classes (improvement, no change, worsening) at Week 6 and Week 12.
-Score of each ocular symptom throughout the day and the sum of these scores.
-Score of each ocular symptom upon instillation and the sum of these scores.
-Score of each ocular sign.
-Corneal fluorescein staining (Oxford grading scheme).
-Far Best Corrected Visual Acuity expressed in Log MAR.
-Ocular tolerance assessed by the investigator.
-Ocular tolerance assessed by the patient.
-Ocular and systemic AE by System Organ Class and Preferred Term.

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy secondary Endppoints:
Change from baseline to Week 12 in IOP at the three time points (8:00 am, 10:00 am and 4:00 pm) in the contralateral eye.
Others efficacy endpoints will be analysed:
- Change from baseline to Week 6 in IOP at the three time points (8:00 am; 10:00 am; 4:00 pm) in the worse eye and in the contralateral eye.
- Efficacy assessed by the investigator.

Safety Endpoints:
Visit#2 (Day 1), Visit 3 (week 6) and visit 4 (week 12)

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Investigator-masked

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

Belgium

Estonia

France

Germany

Greece

Italy

Lithuania

Poland

Spain

Tunisia

Ukraine

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

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:

161

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

273

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

374

F.4.2.2

In the whole clinical trial

434

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

2018-08-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-02-24

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