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    Summary
    EudraCT Number:2007-000029-23
    Sponsor's Protocol Code Number:NVG06C103
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000029-23
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome
    A.3.2Name or abbreviated title of the trial where available
    SICCANOVE
    A.4.1Sponsor's protocol code numberNVG06C103
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot applicable
    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 SponsorNovagali Pharma S.A.
    B.1.3.4CountryFrance
    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 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 nameNot applicable
    D.3.2Product code NOVA22007
    D.3.4Pharmaceutical form Eye drops*
    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 INNCICLOSPORIN
    D.3.9.1CAS number 59865133
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Keratoconjunctivitis sicca (KCS), or dry eye syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10023350
    E.1.2Term Keratoconjunctivitis sicca
    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 the superiority of NOVA22007 (CsA 0.1%) ophthalmic cationic emulsion, administered once daily versus Vehicle in patients with moderate to severe dry eye syndrome after a 6-month treatment period
    E.2.2Secondary objectives of the trial
    To compare the ocular tolerance and systemic safety of NOVA22007 (CsA 0.1%) ophthalmic cationic emulsion administered once daily versus Vehicle in patients with moderate to severe dry eye syndrome, after a 6-month treatment period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females 18 years of age or greater.
    2. At baseline, moderate to severe dry eye condition persisting despite conventional management (which may include artificial tear drops, gels or ointments and punctual occlusion), and defined as the following:
    • At least one moderate to severe symptom of dry eye with a score ≥2 (severity graded on a 4-point scale) i.e., burning/stinging, foreign body sensation, itching, eye dryness, pain, blurred vision or sticky feeling and photophobia AND
    • Tear Break Up time ≤ 8 seconds AND
    • Corneal fluorescein staining ≥ 2 and ≤ 4 (modified Oxford scale, scale 0-5) AND
    • Schirmer tear test without anaesthesia of ≥ 2mm/5min and <10 mm/5min AND
    • Lissamine green staining > 4 (Van Bijsterveld scale, scale 0-9)
    The same eye (eligible eye) should fulfil all the above criteria.
    3. Patient must provide written informed consent.
    4. Patient must be willing and able to undergo and return for scheduled study-related examinations.
    E.4Principal exclusion criteria
    1. Best corrected distance visual acuity (BCDVA) score > + 0.7 Log Mar in the eligible eye.
    2. Dry eye resulting from the destruction of conjunctival goblet cells or scarring.
    3. Abnormal lid anatomy or blinking function.
    4. Abnormalities of the nasolachrymal drainage system.
    5. Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
    6. Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
    7. Any ocular surgery or laser (including palpebral, refractive and cataract surgery/laser) within 6 months before study entry in the eligible eye and within 3 months prior study entry in the non-eligible eye.
    8. History of ocular trauma, infection (viral, bacterial, fungal), or ocular inflammation (Tyndall ≠ 0) as well as ocular inflammation signs not associated with KCS within the 3 months before the Screening Visit.
    9. Patients with severe blepharitis not related to dry eye or Sjögren syndrome, acute lesions of rosacea and/or progressive pterygium.
    10. Any other ocular diseases requiring topical ocular treatment during the study period.
    11. Presence or history of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.
    12. Active or history of ocular herpes.
    13. History of malignancy in the last 5 years (with the exception of basal cell carcinoma and cervix carcinoma).
    14. Systemic disease not stabilized within 1 month before the Screening Visit (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or condition incompatible with the frequent assessments needed by the study.
    15. Known hypersensitivity to one of the components of the study or procedural medications (fluorescein, lissamine green, oxybuprocaine, etc.).
    16. Presence or history of severe systemic allergy.
    17. Any change within 1 month prior study entry of systemic medication that could affect a dry eye condition (e.g., estrogen-progesterone or other estrogen derivatives (only for post-menopausal women), antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, phenothiazines, omega-3, systemic corticosteroids, etc…). These treatments are allowed during the study provided they remain stable throughout the course of the study.
    18. Use of systemic or topical CsA (i.e., Restasis™), tacrolimus or sirolimus, within 6 months prior study entry.
    19. Use of topical corticosteroids or prostaglandins within one month before study entry.
    20. Any change within 1 month prior study entry of systemic pilocarpine, isotretinoine or tetracycline, as well as the use of topical pilocarpine or isotretinoine within 1 month before study entry. The systemic treatments (pilocarpine, isotretinoine or tetracycline) are allowed during the study provided they remain stable throughout the course of the study.
    21. Use of topical antihistaminics, dual agents, betablocking agents or antibiotics within 2 weeks before study entry.
    22. Any change in systemic immunosuppressant drugs within 1 month before study entry.
    23. Any concomitant topical ocular treatment other than the study medications and concomitant tear substitute provided.
    24. Contact lens wears during the study.
    25. Anticipated use of temporary punctum plugs during the study. Prior punctal plugs are allowed provided they were inserted at least one month before study entry and they remain in situ during the study.
    26. Any planned refractive surgery (LASIK, LASEK, PRK, etc) during the course of the study.
    27. Pregnancy or lactation at study entry.
    28. Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as implants, injectables or oral contraceptives together with condoms, some intra-uterine devices, sexual abstinence or vasectomised partner) throughout the conduct of the study up to two weeks after study end. The post-menopausal women (two years without menstruation) do not need to use any method of birth control.
    29. Presence or history of drug addiction or alcohol abuse.
    30. Patient who has participated in a clinical trial with a new active substance during the past month before study entry.
    31.Participation in another clinical study at the same time as the present study.
    E.5 End points
    E.5.1Primary end point(s)
    • Corneal fluorescein staining (on modified Oxford scale)
    • Patient’s global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%–100%
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    Not applicable
    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 months25
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 482
    F.4.2.2In the whole clinical trial 482
    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)
    Not applicable
    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 Decision2007-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-08
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