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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-019507-28
    Sponsor's Protocol Code Number:C-09-055
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-11
    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.1Member State ConcernedSweden - MPA
    A.2EudraCT number2010-019507-28
    A.3Full 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.3.2Name or abbreviated title of the trial where available
    Confirmatory Study Nepafenac 0.3%
    A.4.1Sponsor's protocol code numberC-09-055
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlcon Research, Ltd.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NEVANAC 1 mg/ml eye drops, suspension
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK) Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNepafenac 3 mg/ml eye drops, suspension
    D.3.2Product code AL-6515
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEPAFENAC
    D.3.9.1CAS number 78281-72-8
    D.3.9.2Current sponsor codeAL-6515
    D.3.9.3Other descriptive nameNepafenac
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEPAFENAC
    D.3.9.1CAS number 78281-72-8
    D.3.9.2Current sponsor codeAL-6515
    D.3.9.3Other descriptive nameNepafenac
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops*
    D.8.4Route of administration of the placeboOcular use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops*
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In 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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-25
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