Clinical Trials Register

Summary
EudraCT Number:	2010-019507-28
Sponsor's Protocol Code Number:	C-09-055
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-07-22
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2010-019507-28

A.3

Full title of the trial

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery

A.3.2

Name or abbreviated title of the trial where available

Confirmatory Study Nepafenac 0.3%

A.4.1

Sponsor's protocol code number

C-09-055

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Alcon Research, Ltd.
B.1.3.4	Country	United States
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
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	NEVANAC 1 mg/ml eye drops, suspension
D.2.1.1.2	Name of the Marketing Authorisation holder	Alcon Laboratories (UK) Ltd.
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.3.1	Product name	NEVANAC
D.3.4	Pharmaceutical form	Eye drops, suspension
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	NEPAFENAC
D.3.9.1	CAS number	78281-72-8
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	1 to 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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	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	Nepafenac 3 mg/ml eye drops, suspension
D.3.2	Product code	AL-6515
D.3.4	Pharmaceutical form	Eye drops, suspension
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	NEPAFENAC
D.3.9.1	CAS number	78281-72-8
D.3.9.2	Current sponsor code	AL-6515
D.3.9.3	Other descriptive name	Nepafenac
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	3
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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 drops*
D.8.4	Route of administration of the placebo	Ocular use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Eye drops*
D.8.4	Route of administration of the placebo	Ocular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery

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

To demonstrate that:
1) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is not inferior to NEVANAC dosed three times daily for the prevention and treatment of ocular inflammation 14 days after cataract extraction.
2) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is superior to its vehicle dosed once daily for the prevention and treatment of ocular inflammation 14 days after cataract extraction.
3) NEVANAC dosed three times daily is superior to its vehicle dosed three times daily for the prevention and treatment of ocular inflammation 14 days after cataract extraction.

E.2.2

Secondary objectives of the trial

To demonstrate that:
1) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is not inferior to NEVANAC dosed three times daily for the prevention and treatment of ocular pain as assessed by the Investigator 14 days after cataract extraction.
2) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is superior to its vehicle dosed once daily for the prevention and treatment of ocular pain as assessed by the Investigator 14 days after cataract extraction.
3) NEVANAC dosed three times daily is superior to its vehicle dosed three times daily for the prevention and treatment of ocular pain as assessed by the Investigator 14 days after cataract extraction.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men or women of any race, 18 years or older who have cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens.

2. Study eye of patients who in the opinion of the investigator will have improvement in bestcorrected
visual acuity after surgery.

3. Patients should be able to understand and sign an informed consent that has been approved by an Institutional Review Board/Independent Ethics Committee. Note: Legally authorized representative of the patient can provide informed consent.

E.4

Principal exclusion criteria

1. Planned multiple procedures during cataract/IOL implantation surgery (eg.
trabeculectomy, corneal transplant). Note: A planned limbal relaxing incision may be
performed for the correction of astigmatism
2. Use of topical, topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit
3. Use of topical, topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit
4. Use of a topical, topical ophthalmic prostaglandin in the operative eye (eg travoprost, latanoprost, bimatoprost, tafluprost). Patients with a previous history of topical ophthalmic prostaglandin use must discontinue at least 4 days prior to surgery and through study exit.
5. Any intraocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain greater than Grade 1 in the study eye that is present during the Baseline visit
6. Previous ocular trauma to the operative eye (this includes cataract and previous
intraocular surgery, where a wound is created to gain access to the anterior or posterior segments; this does not include previous laser therapy without use of an incision)
7. A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis,iridocyclitis, rubeosis iridis) in the operative eye
8. Patients who in the opinion of the investigator are at increased risk of developing
postoperative macular edema (eg. diabetic retinopathy) in the operative eye
9. Currently diagnosed uncontrolled glaucoma in the operative eye
10. Lens pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye
11. Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye
12. A visually nonfunctional fellow eye defined as a best-corrected visual acuity ≤ 35 ETDRS letters (20/200 Snellen equivalent) or worse
13. Participation in any other investigational drug or device study within 30 days before cataract surgery
14. Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article
15. Women of childbearing potential (those who are not surgically sterilized or
post menopausal) may not participate in the study if any of the following conditions exist:
a. they are breast-feeding;
b. they have a positive urine pregnancy test at screening;
c. they are not willing to undergo a urine pregnancy test upon entering or exiting the
study;
d. they intend to become pregnant during the duration of the study; or,
e. they do not agree to use adequate birth control methods for the duration of the
study (adequate birth control methods are: hormonal - oral, implantable, or
injectable contraceptives; mechanical - spermicide in conjunction with a barrier
such as condom or diaphragm; IUD; or, surgical sterilization of partner)

In addition, an Alcon Medical Monitor may declare any patient ineligible for a valid medical reason.

E.5 End points

E.5.1

Primary end point(s)

The proportion of patients with clinical cure at day 14. Clinical cure is defined as a score of 0 for both aqueous cells and flare.

To be defined as a clinical cure at days 1, 3 or 7, a patient must meet the definition for the primary endpoint of a clinical cure (a score of 0 for both aqueous cells and flare) at that timepoint and at all subsequent assessed timepoints.

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)

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)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

Information not present in EudraCT

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

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

LPLV

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	300
F.4.2	For a multinational trial
F.4.2.1	In the EEA	600
F.4.2.2	In the whole clinical trial	2000

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

2010-10-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-10-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-05-25

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