Clinical Trials Register

Summary
EudraCT Number:	2020-003979-18
Sponsor's Protocol Code Number:	LT4030-301
National Competent Authority:	Bulgarian Drug Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-08
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

Bulgarian Drug Agency

A.2

EudraCT number

2020-003979-18

A.3

Full title of the trial

Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD
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 T4030 Eye Drops versus Ganfort® UD
in Ocular Hypertensive or Glaucomatous Patients.

A.4.1

Sponsor's protocol code number

LT4030-301

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	Research and Development 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	63017
B.5.3.4	Country	France
B.5.6	E-mail	Sandrine.Guyon@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	unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1%
D.3.2	Product code	T4030
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	T4030
D.3.9.4	EV Substance Code	SUB12470MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.01
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	26921-17-5
D.3.9.2	Current sponsor code	T4030
D.3.9.3	Other descriptive name	Timololi maleas (Ph. Eur.)
D.3.9.4	EV Substance Code	SUB11069MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
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.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® UD
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/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.03
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIMOLOL
D.3.9.3	Other descriptive name	Timolol
D.3.9.4	EV Substance Code	SUB11069MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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)	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

Primary open-angle glaucoma or 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 T4030 (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1%) with Ganfort UD (unpreserved fixed combination of bimatoprost 0.03% and timolol 0.5% eye drops) in terms of efficacy.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy and safety of T4030 versus Ganfort UD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Informed consent signed and dated
AT SCREENING (Visit #1):
2. Patient aged ≥18 years old
3. Both eyes with a central corneal thickness assessment ≥500 μm and ≤600 μm assessed within 6 months or during the Screening visit
4. Both eyes with diagnosed ocular hypertension or open angle glaucoma (primary open-angle, pseudoexfoliative or pigmentary glaucoma) currently treated with a first-line monotherapy (PGA or beta-blocker), insufficiently controlled in the opinion of the investigator, and requiring a dual therapy (bitherapy)
AT RANDOMISATION VISIT (Visit #2):
5. IOP ≥22 mmHg in both eyes at 08:00
6. IOP asymmetry between eyes ≤4 mmHg at 08:00
7. IOP <36 mmHg in both eyes at all time points (08:00, 10:00, 16:00)
8. Patient having respected the wash out period of at least 28 days

E.4

Principal exclusion criteria

1. Ophthalmic Exclusion Criteria in AT LEAST ONE EYE
Patient experiencing at Screening visit or having experienced:
1.1 Inability to safely discontinue use of IOP-lowering ocular medication for the specified wash-out period according to the investigator’s judgement
1.2 Visual field not available within previous 6 months and not performed at the Screening visit
1.3 History of narrow angle and/or angle closure glaucoma
1.4 Advanced stage of glaucoma
2. Systemic/non Ophthalmic Exclusion Criteria
Patient experiencing AT Screening or Randomisation visits:
2.1 Uncontrolled diabetes
2.2 Overt cardiac failure, cardiogenic shock
2.3 Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
2.4 Heart rate <50 bpm and/or systolic arterial blood pressure ≤90 mmHg
2.5 Presence or history of reactive airway disease (e.g bronchial asthma or severe chronic obstructive pulmonary disease)
2.6 Any other history of, or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the patient safety according to investigator’s judgement

E.5 End points

E.5.1

Primary end point(s)

1. The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP at 08:00 in the study eye.

E.5.1.1

Timepoint(s) of evaluation of this end point

week 12

E.5.2

Secondary end point(s)

1)Safety and tolerability endpoints:
Frequency distribution and change from Baseline (Day 1) in each eye at week 6 and week 12:
• for the conjunctival hyperaemia on McMonnies scale
• for each ocular sign at slit lamp
• for CFS on Oxford grading scale
Frequency distribution of patients with clinically significant appearance and/or worsening of ocular symptom(s) throughout the day and/or upon instillation
- Far Best-Corrected Visual Acuity (BCVA) expressed in LogMAR
- Ocular tolerance assessed by the investigator
- Ocular tolerance assessed by the patient
- Ocular and systemic treatment-emergent adverse events (TEAE), serious TEAE, drug-related TEAE, TEAE leading to premature IMP discontinuation by System Organ Class (SOC) and Preferred Term (PT).
- Cardiovascular parameters (heart rate and blood pressure)

2)Patient questionnaire outcome:
Scores at Week 6 and Week 12 as assessed by the patient in the quality of life questionnaires (TSS-IOP Questionnaire).

3)efficacy endpoints:
Change from Baseline (Day 1) to Week 12 in IOP at 10:00, 16:00 in the study eye
Change from Baseline (Day 1) to Week 12 in mean diurnal IOP in the study eye
Change from Baseline (Day 1) to Week 12 in IOP at three time points (08:00, 10:00, 16:00) in the contralateral eye
Change from Baseline (Day 1) to Week 12 in mean diurnal IOP in the contralateral eye
Change from Baseline to Week 6 in IOP at three time points (08:00; 10:00; 16:00) in the worse eye and in the contralateral eye
Efficacy assessed by the investigator

E.5.2.1

Timepoint(s) of evaluation of this end point

week 6 and 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

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

India

France

Poland

Bulgaria

Spain

Italy

Belgium

Hungary

Russian Federation

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

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:

280

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

220

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

170

F.4.2

For a multinational trial

F.4.2.1

In the EEA

330

F.4.2.2

In the whole clinical trial

500

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

2021-02-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-04-13

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