Clinical Trials Register

Summary
EudraCT Number:	2016-004358-14
Sponsor's Protocol Code Number:	BVDStudy
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-08
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-004358-14

A.3

Full title of the trial

Bromfenac 0.09% versus dexamethasone 0.1% ophthalmic solutions to reduce inflammation after cataract surgery: the BVD Study.

Comparazione di bromfenac 0.09% collirio versus desametasone 0.1% collirio in pazienti sottoposti ad intervento di cataratta.

A.3.1

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

To compare the efficacy of bromfenac ophthalmic solution 0.09% to dexamethasone ophthalmic solution 0.1% for reducing postoperative inflammation after cataract surgery.

Valutazione dell'efficacia di un collirio anti infiammatorio non steroideo (bromfenac) rispetto al trattamento farmacologico standard (desametasone) per ridurre l'infiammazione postoperatoria dopo l'intervento di cataratta.

A.3.2

Name or abbreviated title of the trial where available

BVD Study

A.4.1

Sponsor's protocol code number

BVDStudy

A.5.4

Other Identifiers

Name:

BVD Study

Number:

BVD Study

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	AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	A.O. di Reggio Emilia Arcispedale "S. Maria Nuova"
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	A.O. di Reggio Emilia Arcispedale "S. Maria Nuova"/IRCCS
B.5.2	Functional name of contact point	S.C. Oculistica
B.5.3	Address:
B.5.3.1	Street Address	Viale Risorgimento n. 80
B.5.3.2	Town/ city	Reggio Emilia
B.5.3.3	Post code	42123
B.5.3.4	Country	Italy
B.5.4	Telephone number	0522296219
B.5.5	Fax number	0522295890
B.5.6	E-mail	marco.coassin@asmn.re.it

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	Yes
D.2.1.1.1	Trade name	YELLOX - 0.9 MG/ML - COLLIRIO, SOLUZIONE - USO OFTALMICO - FLACONE (PE) - 5 ML 1 FLACONE
D.2.1.1.2	Name of the Marketing Authorisation holder	CROMA-PHARMA GMBH
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Yellox 0,9 mg/ml collirio, soluzione
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	BROMFENAC
D.3.9.1	CAS number	91714-94-2
D.3.9.2	Current sponsor code	Bromfenac
D.3.9.3	Other descriptive name	BROMFENAC
D.3.9.4	EV Substance Code	SUB05913MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	66
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	VISUMETAZONE - 0.1% COLLIRIO, SOSPENSIONE FLACONE 3 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	VISUFARMA S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	VISUMETAZONE 0,1% collirio sospensione
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	DESAMETASONE
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	Desametasone
D.3.9.3	Other descriptive name	Desametasone
D.3.9.4	EV Substance Code	SUB07017MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Postoperative ocular inflammation after cataract surgery

Infiammazione oculare dopo intervento di cataratta

E.1.1.1

Medical condition in easily understood language

Patients with cataract undergoing cataract surgery

I pazienti inclusi nello studio sono soggetti affetti da cataratta sottoposti ad intervento di facoemulsificazione (= rimozione della cataratta).

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

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	10015943
E.1.2	Term	Eye inflammation
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

1. To describe the time since to the intervention needed to revert the postoperative flare to the preoperative or lower level within the group treated with bromfenac ophthalmic solution 0.09% and, separately, within the group treated with dexamethasone ophthalmic solution 0.1% for reducing postoperative ocular inflammation after cataract surgery;
2. To compare the proportion of patients who will have a postoperative flare at day 14 equal or inferior to the preoperative value in the group treated with bromfenac ophthalmic solution 0.09% vs. the ones treated with dexamethasone ophthalmic solution 0.1%.

1. Descrivere il tempo necessario a riportare l'infiammazione postoperatoria a valori uguali o inferiori a quelli preoperatori sia nel gruppo trattato con bromfenac collirio 0,09% sia, separatamente, nel gruppo trattato con desametasone collirio 0,1% dopo l'intervento di cataratta.
2. Confrontare la porzione di pazienti con infiammazione postoperatoria al giorno 14 uguale o inferiore a quella preoperatoria nel gruppo di pazienti trattati con Bromfenac 0,09% vs il gruppo trattato con desametasone 0,1%.

E.2.2

Secondary objectives of the trial

1) Best corrected visual acuity (BCVA)
2) Macular thickness at OCT (Subclinical cystoid macular edema)
3) Safety: Ocular Comfort Grading Assessment (OCGA)
4) All Adverse Events

1. Acuit¿ visiva
2. Spessore maculare misurato con OCT (edema maculare)
3. Sicurezza: Scala del comfort Oculare
4. Eventi Avversi

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patients that underwent uneventful cataract surgery;
-Patients aged >60 year old (for women, the menopausal state is assumed);
-A signed informed consent for this study protocol is mandatory.

- Pazienti operati di cataratta in assenza di complicanze intraoperatorie;
- Età superiore/uguale ai 60 anni (per le donne si assume stato post menopausa);
- Adesione allo studio BVD con sottoscrizione di specifico consenso.

E.4

Principal exclusion criteria

Patients with history of ocular inflammation or trauma, previous intraocular surgery, corneal haze, pseudoexfoliatio lentis, retinal vascular disease, diabetic retinopathy, variation of the foveal profile at OCT (including macular edema and epiretinal membrane), moderate to severe age related macular degeneration.
Patients could not be enrolled in another clinical study concurrently.

- Pazienti con storia di infiammazioni oculari o trauma, pregressa chirurgia oculare, opacità corneali, pseudoexfoliatio lentis, malattie vascolari retiniche, retinopatia diabetica, edema maculare, membrana epiretinica, degenerazione maculare senile di grado moderato o severo;
- Arruolamento in contemporanea in altro studio clinico

E.5 End points

E.5.1

Primary end point(s)

1) Time since the intervention needed to revert the postoperative flare to the preoperative or lower level. Flare will increase the day after surgery and then likely decrease towards baseline values in all patients. Patients will be evaluated by Laser Flare Photometry (LFP) at postoperative day 3, 7, 9, 11, 14 and 30. LFP is a new, non invasive, objective method to measure inflammation in the anterior chamber of the eye;
2) proportion of patients who will have a postoperative flare at day 14 equal or inferior to the preoperative value in the group treated with bromfenac ophthalmic solution 0.09% vs. the ones treated with dexamethasone ophthalmic solution 0.1%, where the flare will be assessed as described for the first primary endpoint.

1) Dopo l'intervento di cataratta è necessario ridurre l'infiammazione postoperatoria a livelli uguali o inferiori del valore preoperatorio. L'infiammazione aumenta il giorno dopo l'intervento e poi decresce fino a raggiungere i valori preoperatori. L'infiammazione dei pazienti in studio verrà misurata, attraverso il Laser Flare Photometry (LFP) il giorno dopo l'intervento, dopo 3, 7, 9, 11, 14 e 30 giorni. Il LFP è una tecnica non ivasiva che permette di misurare l'infiammazione oculare nella camera anteriore dell'occhio.
2) Confrontare la porzione di pazienti con infiammazione postoperatoria al giorno 14 uguale o inferiore a quella preoperatoria nel gruppo di pazienti trattati con Bromfenac 0,09% vs il gruppo trattato con desametasone 0,1%.

E.5.1.1

Timepoint(s) of evaluation of this end point

14 day after surgery

14 giorno post operatorio

E.5.2

Secondary end point(s)

Best corrected visual acuity (BCVA); Macular thickness (Subclinical cystoid macular edema); Safety endpoint: Ocular Comfort Grading Assessment (OCGA); All Adverse Events

Acuit¿ visiva; Spessore maculare misurato con Tomografia a coerenza ottica (OCT)(Edema maculare cistoide subclinico); Sicurezza: Scala del conforto Oculare; Eventi Avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

¿ 3 giorni
¿ 7 giorni
¿ 9 giorni
¿ 11 giorni
¿ 14 giorni
¿ 30 giorni
; 30 days; ¿ 3 giorni
¿ 7 giorni
¿ 9 giorni
¿ 11 giorni
¿ 14 giorni
¿ 30 giorni
; ¿ 3 giorni
¿ 7 giorni
¿ 9 giorni
¿ 11 giorni
¿ 14 giorni
¿ 30 giorni

¿ 3 giorni
¿ 7 giorni
¿ 9 giorni
¿ 11 giorni
¿ 14 giorni
¿ 30 giorni
; 30 giorni; ¿ 3 giorni
¿ 7 giorni
¿ 9 giorni
¿ 11 giorni
¿ 14 giorni
¿ 30 giorni
; ¿ 3 giorni
¿ 7 giorni
¿ 9 giorni
¿ 11 giorni
¿ 14 giorni
¿ 30 giorni

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

E.6.5

Efficacy

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in 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

Information not present in EudraCT

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:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

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)

After the end of the study, the assistance to the participants will be guaranteed at any time by the ophthalmologists of the Department of Ophthalmology through the Emergency Room of the Arcispedale Santa Maria Nuova, Reggio Emilia (in the same way of the other patients not included in the study who routinely undergo cataract surgery in our hospital).

I partecipanti allo studio, successivamente al completamento dello stesso, potranno accedere in qualsiasi momento all¿assistenza garantita dai medici oculisti della S.C. di Oculistica tramite il Pronto Soccorso dell¿Arcispedale Santa Maria Nuova di Reggio Emilia in modo del tutto analogo agli altri pazienti non inclusi nello studio che routinariamente vengo operati di cataratta nella nostra struttura.

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

2017-01-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-14

P. End of Trial
P.	End of Trial Status	Ongoing

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