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    Summary
    EudraCT Number:2013-004271-12
    Sponsor's Protocol Code Number:NGF0213
    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:2013-11-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-004271-12
    A.3Full title of the trial
    An open-label study evaluating safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops at different doses in patients with Dry Eye
    Eine offene Studie zur Evaluierung der Sicherheit und Wirksamkeit von rekombinantem humanen Nervenwachstumsfaktor (rhNGF) enthaltenden Augentropfen in unterschiedlichen Dosierungen in Patienten mit Syndrom des trockenen Auges
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label study evaluating safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops at different doses in patients with Dry Eye
    Eine offene Studie zur Evaluierung der Sicherheit und Wirksamkeit von rekombinantem humanen Nervenwachstumsfaktor (rhNGF) enthaltenden Augentropfen in unterschiedlichen Dosierungen in Patienten mit Syndrom des trockenen Auges
    A.3.2Name or abbreviated title of the trial where available
    Pilot study of rhNGF to treat Dry Eye Disease
    A.4.1Sponsor's protocol code numberNGF0213
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDompé s.p.a
    B.1.3.4CountryItaly
    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 supportDompé s.p.a
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé spa
    B.5.2Functional name of contact pointMedical Expert
    B.5.3 Address:
    B.5.3.1Street Address Via S. Martino 12
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number+3902583831
    B.5.5Fax number+390258383324
    B.5.6E-mailfrancesco.sinigaglia@dompe.it
    D. IMP Identification
    D.IMP: 1
    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 nameRecombinant human nerve growth factor
    D.3.2Product code rhNGF
    D.3.4Pharmaceutical form Ear/eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ophthalmic use (Noncurrent)
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Human Nerve Growth Factor
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN NERVE GROWTH FACTOR (RHNGF)
    D.3.9.4EV Substance CodeSUB77552
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.06
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 nameRecombinant human nerve growth factor
    D.3.2Product code rhNGF
    D.3.4Pharmaceutical form Ear/eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ophthalmic use (Noncurrent)
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant human nerve growth factor
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN NERVE GROWTH FACTOR (RHNGF)
    D.3.9.4EV Substance CodeSUB77552
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.02
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dry Eye syndrome is caused by either decreased tear production or increased tear film evaporation.
    Dry eye is a chronic inflammatory condition of the ocular surface with severe symptoms and visual impairment, leading to worse efficiency to perform duties
    E.1.1.1Medical condition in easily understood language
    Dry eyes occur when your tears aren't able to provide adequate moisture for your eyes. Tears can be inadequate for many reasons.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10013777
    E.1.2Term Dry eye syndrome
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy and safety of different doses of
    rhNGF when administered as eye drops to patients with Dry Eye.
    on the basis of the following assessments:
    - Symptom Assessment in Dry Eye (SANDE)
    - Ocular surface vital staining (National Eye Institute [NEI] scales)
    - Schirmer test type I (without anaesthesia)
    performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be
    evaluated.
    - Treatment-emergent adverse events (TEAEs), assessed throughout the study
    E.2.2Secondary objectives of the trial
    Evaluation of the clinical efficacy and safety during and at the end of treatment with rhNGF,
    on the basis of the following assessments:
    - Visual analogue scale (VAS) for (foreign body sensation, burning/stinging, itching, pain,
    stick feeling, blurred vision and photophobia)
    - Slit lamp examination (Eyelid - Meibomian glands, Eyelid – Erythema, Eyelid - Oedema
    Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber)
    - Schirmer test type II (with anaesthesia)
    - Tear Film Break-Up Time (TFBUT)
    - Corneal sensitivity (Cochet-Bonnet aesthesiometry)
    - Intraocular Pressure (IOP)
    - Ocular Surface Disease Index (OSDI)
    - Visual acuity
    - Fundus ophthalmoscopy
    - Tear Film osmolarity
    - Conjunctival impression cytology for goblet cells' count
    - Frequency of artificial tears use
    performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be evaluated.
    - Vitals signs, body weight (BW), physical examinations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients, ≥ 18 years old;
    2. Required use of artificial tears for the treatment of Dry Eye within the 3 months prior to study enrolment;
    3. Current use or recommended use of artificial tears for the treatment of Dry Eye;
    4. Average VAS scores for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm;
    5. Corneal staining score > 3 using the NEI corneal grading system in the worse eye (study eye);
    6. Conjunctival staining score > 3 using the NEI conjunctival grading system in the worse eye (study eye);
    7. Schirmer test without anaesthesia ≤ 10 mm/5 minutes in the worse eye (study eye);
    8. Tear film break-up time (TFBUT) ≤ 10 seconds in the worse eye (study eye).
    E.4Principal exclusion criteria
    1. Patient not suitable to participate in the study in the opinion of the investigator;
    2. Patient with a mild or moderate Dry Eye condition (severity level less than 3 according to the Report of the International Dry Eye Workshop -DEWS, 2007) if fourteen (14) patients with mild or moderate dry eye condition have been already enrolled in the current treatment group (Group 1 and Group 2 separately);
    3. Patient has had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or has a clinically significant allergy to drugs, foods, amide local anaesthetics or other materials including commercial artificial tears containing Hypromellose (in the opinion of the investigator);
    4. Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment. Use of own artificial tears is allowed until Visit 2;
    5. Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye within 30 days of study enrolment;
    6. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye;
    7. Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results;
    8. Use of therapeutic or Refractive Contact lenses in either eye within 30 days of study enrolment;
    9. History of ocular surgery in the study eye, including corneal refractive procedures, within 90 days of study enrolment;
    10. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
    a. are currently pregnant or,
    b. have a positive result at the urine pregnancy test (screening/Day 1) or,
    c. intend to become pregnant during the study treatment period or,
    d. are breast-feeding or,
    e. are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral,
    implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction
    with a barrier such as a condom or diaphragm or IUD - during the entire course of and 30 days after the
    study treatment periods.
    11. Participation in another clinical study at the same time as the present and within 30 days of study enrolment;
    12. History of drug, medication or alcohol abuse or addiction.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the clinical efficacy and safety during and at the end of treatment with rhNGF, on the basis of the
    following assessments:
    - Symptom Assessment in Dry Eye (SANDE)
    - Ocular surface vital staining (National Eye Institute [NEI] scales)
    - Schirmer test type I (without anaesthesia)
    performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be evaluated.
    - Treatment-emergent adverse events (TEAEs), assessed throughout the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    days 1, 8±1, 29±1 and 56±4.
    E.5.2Secondary end point(s)
    Study end-points, continued:
    Secondary end-points:
    Evaluation of the clinical efficacy and safety during and at the end of treatment with rhNGF, on the basis of the following assessments:
    - Visual analogue scale (VAS) for (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia)
    - Slit lamp examination (Eyelid - Meibomian glands, Eyelid –Erythema, Eyelid - Oedema Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber)
    - Schirmer test type II (with anaesthesia)
    - Tear Film Break-Up Time (TFBUT)
    - Corneal sensitivity (Cochet-Bonnet aesthesiometry)
    - Intraocular Pressure (IOP)
    - Ocular Surface Disease Index (OSDI)
    - Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] chart)
    - Fundus ophthalmoscopy
    - Tear Film osmolarity
    - Conjunctival impression cytology for goblet cells' count
    - Frequency of artificial tears use
    performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be evaluated.
    - Vitals signs (blood pressure; BP, pulse rate; PR), body weight (BW), physical examinations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    days 1, 8±1, 29±1 and 56±4
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single-centre, two-group, two doses, efficacy and safety exploratory study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    last visit od last subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) No
    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 state40
    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
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-30
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