Clinical Trials Register

Summary
EudraCT Number:	2021-000147-45
Sponsor's Protocol Code Number:	YS001
National Competent Authority:	Greece - EOF
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-03-11
Trial 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

Greece - EOF

A.2

EudraCT number

2021-000147-45

A.3

Full title of the trial

A non-inferiority, randomized, investigator - masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost (YSLT) versus a reference drug (Xalatan®) in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) – The COMET Study

Μια μη-κατωτερότητας, τυχαιοποιημένη, τυφλή ως προς τον ερευνητή, δύο παράλληλων ομάδων, φάσης III κλινική δοκιμή, για την αξιολόγηση της αποτελεσματικότητας και της ασφάλειας ενός σκευάσματος λατανοπρόστης χωρίς συντηρητικό (YSLT) έναντι ενός φαρμάκου αναφοράς (Xalatan®) σε ασθενείς με πρωτογενές γλαύκωμα ανοικτής γωνίας (ΠΓΑΓ/POAG) ή οφθαλμική υπέρταση (ΟΥ/OHT) – Η Μελέτη COMET

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

ΜΕΛΕΤΗ COMET

A.4.1

Sponsor's protocol code number

YS001

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	YONSUNG GMBH
B.1.3.4	Country	Germany
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	YONSUNG GMBH
B.4.2	Country	Greece
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pharmabide Ltd
B.5.2	Functional name of contact point	CLINICAL OPERATIONS
B.5.3	Address:
B.5.3.1	Street Address	31 Pentelis ave.
B.5.3.2	Town/ city	Athens
B.5.3.3	Post code	15235
B.5.3.4	Country	Greece
B.5.4	Telephone number	00302106827177
B.5.6	E-mail	clinicaloperations@pharmabide.gr

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	YSLT Latanoprost 50 μg/mL Eye Drop Solution
D.3.4	Pharmaceutical form	Eye drops, solution in single-dose container
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.11 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	XALATAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Pharma PFE GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Xalatan 50 micrograms/mL Eye drops, solution
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.3.11 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, OCCULAR HYPERTENSION

Γλαύκωμα / Υψηλή πίεση στα μάτια

E.1.1.1

Medical condition in easily understood language

GLAUCOMA, OCCULAR HYPERTENSION

Γλαύκωμα / Υψηλή πίεση στα μάτια

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to demonstrate the clinical non-inferiority of the YSLT latanoprost 50μg/ml eye drops solution Yonsung GmbH (test product) in lowering intra-ocular pressure (IOP) in patients with POAG and OHT as compared to latanoprost 50μg/ml eye drops solution product Xalatan®, Pfizer (reference product).

Να καταδειχθεί η κλινική μη κατωτερότητα του διαλύματος οφθαλμικών σταγόνων λατανοπρόστης 50μg/ml YSLT της Yonsung GmbH (προϊόν δοκιμής) στη μείωση της ενδοφθάλμιας πίεσης (ΕΠ/IOP) σε ασθενείς με ΠΓΑΓ/POAG και ΟΥ/OHT σε σύγκριση με το διάλυμα οφθαλμικών σταγόνων λατανοπρόστης 50μg/ml του προϊόντος Xalatan® της Pfizer Ltd (προϊόν αναφοράς).

E.2.2

Secondary objectives of the trial

• to assess the levels of conjunctival hyperaemia induced in the test and reference product,
• to assess the efficacy of test vs reference product in IOP change after 4 weeks of treatment,
• to assess the safety profile of treatments considered.

-Η αξιολόγηση των επιπέδων της υπεραιμίας του επιπεφυκότα που προκαλείται από το προϊόν δοκιμής και αναφοράς,
-Η αξιολόγηση της αποτελεσματικότητας του προϊόντος δοκιμής έναντι του προϊόντος αναφοράς στη μεταβολή της ΕΠ/IOP έπειτα από 4 εβδομάδες θεραπείας,
-Η αξιολόγηση του προφίλ ασφάλειας των εξεταζόμενων θεραπειών

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Written informed consent obtained from the subject or legal representative before any trial assessment.
2) Male or female, of any race and ≥18 years of age.
3) Diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension.
4) The IOP is between ≥ 22 mm Hg and ≤ 35 mm Hg in at least one eye at the time of screening (single measurement) and at baseline (average IOP measured at 09:00, 12:00 and 16:00 hours pre-treatment).
5) Without treatment for primary open-angle glaucoma or OHT with IOP-lowering drugs for at least 4 weeks (wash out period of 4 weeks) prior to baseline.
6) Best-corrected visual acuity ≥20 of 100 (Snellen) corresponding to logarithm of minimal angle of resolution (logMAR) score of 0.7.
7) No new systemic medication that may alter IOP (e.g., beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.) during the 30 days prior baseline. If the patient is currently treated with these medicinal products is expected to receive a stable regimen for 30 days prior to baseline that will be followed throughout the duration of the trial.
8) Subjects with controlled arterial blood pressure according to the judgment of the investigator.
9 Expected, as judged by the Investigator, that IOP will remain controlled with the IMP treatment without optic nerve damage or progression of visual field loss.
10) Able to understand the requirements of the clinical trial and to agree to participate in all trial visits.

1) Γραπτή συναίνεση μετά από ενημέρωση
2) Άνδρας ή γυναίκα, οποιασδήποτε φυλής και ηλικίας ≥18 ετών.
3) Διάγνωση πρωτογενούς γλαυκώματος ανοικτής γωνίας ή οφθαλμικής υπέρτασης.
4) Η ΕΠ/IOP κυμαίνεται μεταξύ ≥ 22 mm Hg και ≤ 35 mm Hg σε τουλάχιστον έναν οφθαλμό κατά τη διάρκεια της διαλογής και στην έναρξη της θεραπείας
5) Χωρίς θεραπεία για πρωτογενές γλαύκωμα ανοικτής γωνίας ή ΟΥ/OHT για τουλάχιστον 4 εβδομάδες
6) Βέλτιστη διορθωμένη οπτική οξύτητα ≥20 από 100 (Snellen)

E.4

Principal exclusion criteria

1) History of chronic or recurrent inflammatory eye disease, ocular trauma or infections.
2) History of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema.
3) Narrow-angle/angle-closure glaucoma.
4) Corneal abnormalities that will preclude accurate IOP reading with an applanation tonometer.
5) Clinically significant or progressive retinal disease.
6) Intraocular surgery within the 3 months before baseline.
7) Ocular laser surgery within one month before baseline.
8) Current use of topical, ocular, nonsteroidal anti-inflammatory drugs.
9) Treatment with local or systemic corticosteroids.
10) Treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide).
11) History of allergic hypersensitivity or poor tolerance to any component of the eye drop solution (IMP) used in this clinical trial.
12) Current participation or not yet completed period (at least 30 days since the ending) of other investigational device or drug trial(s).
13) Pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant.

1) Ιστορικό χρόνιας ή υποτροπιάζουσας φλεγμονώδους οφθαλμικής νόσου, οφθαλμικού τραύματος ή λοιμώξεων.
2) Ιστορικό φακού πρόσθιου θαλάμου, σχισμένης κάψουλας οπίσθιου φακού, αφακίας ή οποιουδήποτε γνωστού παράγοντα κινδύνου για οίδημα κυστοειδούς ωχράς κηλίδας.
3) Γλαύκωμα στενής/κλειστής γωνίας.
4) Ανωμαλίες του κερατοειδούς που θα αποκλείσουν την ακριβή σάρωση της ΕΠ/IOP με τονόμετρο επιπέδωσης.
5) Κλινικά σημαντική ή εξελισσόμενη νόσος του αμφιβληστροειδούς.
6) Ενδοφθάλμια χειρουργική επέμβαση εντός 3 μηνών πριν από την έναρξη της θεραπείας.
7) Οφθαλμική χειρουργική επέμβαση με λέιζερ εντός ενός μήνα πριν από την έναρξη της θεραπείας.
8) Τρέχουσα χρήση τοπικών, οφθαλμικών, μη στεροειδών αντιφλεγμονωδών φαρμάκων.
9) Θεραπεία με τοπικά ή συστημικά κορτικοστεροειδή.
10) Θεραπεία με από του στόματος αναστολείς καρβονικής ανυδράσης (π.χ. ακεταζολαμίδη, μεθαζολαμίδη, τοπιραμάτη, σουλτάμη, ζονισαμίδη).
11) Ιστορικό αλλεργικής υπερευαισθησίας ή χαμηλής ανεκτικότητας σε οποιοδήποτε συστατικό του διαλύματος οφθαλμικής σταγόνας (ΥΕΦ/IMP) που χρησιμοποιείται σε αυτή την κλινική δοκιμή.
12) Τρέχουσα συμμετοχή σε ή μη ολοκληρωμένη περίοδος (τουλάχιστον 30 ημέρες από το τέλος) κλινικής δοκιμής με άλλο υπό έρευνα ιατροτεχνολογικό προϊόν ή φάρμακο.
13) Δυνατότητα εγκυμοσύνης ή θηλασμού ή τεκνοποίησης χωρίς την προστασία μιας πολύ αποτελεσματικής αντισυλληπτικής μεθόδου.

E.5 End points

E.5.1

Primary end point(s)

Difference in mean change in the mean diurnal IOP from baseline to 12 Weeks of treatment between test and reference products as measured by a Goldmann Applanation Tonometer.
The mean diurnal IOP (mmHg) of the study eye at baseline or at 12 Weeks is calculated as the average of 3 IOP measurements at 9 am (± 30 min), 12 pm (± 30 min) and 4 pm (± 30 min) taken at the visit day.

Η διαφορά στη μέση μεταβολή της μέσης ημερήσιας ενδοφθάλμιας πίεσης από την έναρξη της θεραπείας μέχρι τη12η εβδομάδα θεραπείας μεταξύ των προϊόντων δοκιμής και αναφοράς, όπως μετρήθηκε από ένα τονόμετρο επιπέδωσης Goldmann.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 WEEK

12η εβδομάδα

E.5.2

Secondary end point(s)

• Difference in the mean change from Baseline of conjunctival hyperaemia levels (as described in section 7.7) between test and reference; Baseline to Week 4 and Week 12.
• Difference in mean change from baseline in the mean diurnal IOP at Week 4, between test and reference products as measured by a Goldmann Applanation Tonometer.
The mean diurnal IOP (mmHg) of the study eye is calculated as the average of 3 IOP measurements at 9 am (± 30 min), 12 pm (± 30 min) and 4 pm (± 30 min).
• Incidence and severity of adverse events during treatment with test or reference products.

1. Η διαφορά στη μέση μεταβολή από την έναρξη της θεραπείας των επιπέδων υπεραιμίας του επιπεφυκότα μεταξύ των προϊόντων δοκιμής και αναφοράς; έναρξη της θεραπείας μέχρι τη 4η και τη 12η εβδομάδα.
2. Η διαφορά στη μέση μεταβολή από την έναρξη της θεραπείας της μέσης ημερήσιας ενδοφθάλμιας πίεσης (ΕΠ/IOP) τη 4η εβδομάδα, μεταξύ των προϊόντων δοκιμής και αναφοράς, όπως μετρήθηκε από ένα τονόμετρο επιπέδωσης Goldmann.
3. Η συχνότητα εμφάνισης και η σοβαρότητα των ανεπιθύμητων συμβάντων κατά τη διάρκεια της θεραπείας με τα προϊόντα δοκιμής ή αναφοράς.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Baseline to Week 4 and Week 12.

2) week 4

3)during all study

1) έναρξη της θεραπείας μέχρι τη 4η και τη 12η εβδομάδα,
2) 4η εβδομάδα,
3) όλη τη διάρκεια της μελέτης

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

Yes

E.6.13.1

Other scope of the trial description

NON- INFERIORITY

Μη κατωτερότητας

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

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

Yes

E.8.2.3.1

Comparator description

Xalatan 50 micrograms/mL Eye drops, solution

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

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:

102

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.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

KAMMIA

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

2021-06-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-20

P. End of Trial
P.	End of Trial Status	Completed

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