Clinical Trials Register

Summary
EudraCT Number:	2020-000465-17
Sponsor's Protocol Code Number:	CHL.3-02-2019
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-03-16
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

Austria - BASG

A.2

EudraCT number

2020-000465-17

A.3

Full title of the trial

A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in healthy volunteers

Eine randomisierte, doppelt maskierte, Placebo-Kontrollierte Phase II/III Studie zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit von Chloroprocain 3% Gel Augentropfen in gesunden Erwachsenen

A.3.1

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

An Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in healthy volunteers

Eine Studie zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit von Chloroprocain 3% Gel Augentropfen in gesunden Erwachsenen

A.3.2

Name or abbreviated title of the trial where available

Efficacy Chloroprocaine gel eye drops

A.4.1

Sponsor's protocol code number

CHL.3-02-2019

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	Sintetica S.A.
B.1.3.4	Country	Switzerland
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	Sintetica S.A.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medical University of Vienna
B.5.2	Functional name of contact point	Department of Clinical Pharmacology
B.5.3	Address:
B.5.3.1	Street Address	Waehringer Guertel 18-20
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	+4314040029810
B.5.5	Fax number	+4314040029980
B.5.6	E-mail	klin-pharmakologie@meduniwien.ac.at

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	Chloroprocaine hydrochloride 3% eye gel
D.3.2	Product code	Chloroprocaine hydrochloride 3% eye gel
D.3.4	Pharmaceutical form	Eye gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Conjunctival use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Chloroprocaine hydrochloride
D.3.9.1	CAS number	3858-89-7
D.3.9.2	Current sponsor code	Chloroprocaine hydrochloride 3% eye gel
D.3.9.3	Other descriptive name	CHLOROPROCAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB01232MIG
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	30
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	Eye gel
D.8.4	Route of administration of the placebo	Conjunctival use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

healthy volunteers

E.1.1.1

Medical condition in easily understood language

healthy volunteers

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10024758
E.1.2	Term	Local anaesthesia
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 assess efficacy of Chloroprocaine 3% ophthalmic gel in healthy subjects

E.2.2

Secondary objectives of the trial

To assess safety and local tolerability of Chloroprocaine 3% ophthalmic gel

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed and dated informed consent
2. Healthy male or female aged from 18 to 90 years
3. No clinically significant ocular or systemic disease
4. Ability to orally respond to pain
5. Ability to follow the visit schedule

E.4

Principal exclusion criteria

Ophthalmic exclusion criteria
1. Eye movement disorder (i.e. Nystagmus)
2. Dacryocystitis and all other pathologies of tears drainage system
3. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
4. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
5. History of ocular traumatism, infection or inflammation within the last 3 months
6. Best corrected visual acuity < 1/10
7. Subject already included in the study
8. History of ophthalmic surgical complication (i.e. cystoid macular oedema)
Systemic/non ophthalmic exclusion criteria
9. General history:
9.1 Deafness
9.2 Excessive anxiety
10. Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled hypertension: systolic blood pressure over 200 mmHg, diastolic blood pressure over 100 mmHg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study
11. Allergic history: Known hypersensitivity to one of the components of the study medications or to test products
Specific non-inclusion criteria for women:
12. Pregnancy, lactation
13. Women without an effective method of contraception (i.e. oral contraceptive, intra-uterine device, subcutaneous contraceptive implant)
OR
14. Women not hysterectomised, not menopaused nor surgically sterilized
Exclusion criteria related to general conditions:
15. Inability of subject to understand the study procedures and thus inability to give informed consent
16. Non-compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
17. Participation in another clinical study
18. Already included once in this study
19. Ward of court
20. Subject not covered by the Social Security
Exclusion criteria related to previous and concomitant medications (taken within 15 days prior screening visit)
21. Use of systemic opioids and morphinic drugs
22. Topical ocular treatment with anaesthetic action
23. Use of systemic analgesic drugs (except paracetamol, which will be allowed after Visit 2)

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects gaining full anesthesia of the ocular surface 5 minutes after administration of Chloroprocaine 3% ophthalmic gel

E.5.1.1

Timepoint(s) of evaluation of this end point

5 minutes after instillation of IMP

E.5.2

Secondary end point(s)

• Safety and tolerability as assessed by the occurrence of ocular symptoms, adverse event occurrence and concomitant medication
• Time of anesthesia and duration of anesthesia, as well as Cochet Bonnet assessments
• Blood pressure and heart rate
• Slit lamp examination
• Corneal fluorescein staining
• Intraocular pressure

E.5.2.1

Timepoint(s) of evaluation of this end point

- Visit 2 (Day of administration)
- Visit 3 (1 day after administration, phone visit)
- Visit 4 (7 +/- 1 days after administration)
- Visit 5 (18 +/-3 days after administration, phone visit)

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)

Yes

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)

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

Yes

E.8.4

The trial involves multiple sites in the 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

Yes

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

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

Yes

F.3.2

Patients

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.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)

Not applicable - healthy volunteers

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

2020-06-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-12-03

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