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    Summary
    EudraCT Number:2017-003285-27
    Sponsor's Protocol Code Number:T1565-PIV-0117
    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:2017-08-16
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-003285-27
    A.3Full title of the trial
    Clinical efficacy of topical hydrocortisone 0.335% (Softacort®) in patients with chronic dry eye disease and associated ocular surface inflammation
    Klinische Effektivität von Softacort® Augentropfen (Hydrokortison 0.335%) in Patienten mit chronischem trockenen Auge assoziiert mit Entzündung der Augenoberfläche
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of topical hydrocortisone 0.335% (Softacort®) on ocular surface inflammation in patients with dry eye
    Wirkung von Softacort® Augentropfen (Hydrokortison 0.335%) auf die Entzündung der Augenoberfläche in Patienten mit trockenem Auge
    A.3.2Name or abbreviated title of the trial where available
    Softacort Study
    A.4.1Sponsor's protocol code numberT1565-PIV-0117
    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 SponsorLaboratoires Thea
    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 supportLaboratoires Thea
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratoires Thea
    B.5.2Functional name of contact pointLaboratoires Thea
    B.5.3 Address:
    B.5.3.1Street Address12 rue Louis Bleriot
    B.5.3.2Town/ cityClermont-Ferrand Cedex 2
    B.5.3.3Post code63012
    B.5.3.4CountryFrance
    B.5.4Telephone number+33473981400
    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 Yes
    D.2.1.1.1Trade name Softacort 3,35 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Thea
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSoftacort
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    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 INNHYDROCORTISONE SODIUM PHOSPHATE
    D.3.9.1CAS number 6000-74-4
    D.3.9.3Other descriptive nameSoftacort
    D.3.9.4EV Substance CodeSUB02568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.12
    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) 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 No
    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 Yes
    D.2.1.1.1Trade name Softacort 3,35mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Thea
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSoftacort
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    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 INNHYDROCORTISONE SODIUM PHOSPHATE
    D.3.9.1CAS number 6000-74-4
    D.3.9.3Other descriptive nameSoftacort
    D.3.9.4EV Substance CodeSUB02568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.12
    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) 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 No
    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 Disease
    E.1.1.1Medical condition in easily understood language
    Dry Eye Disease
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To evaluate the clinical efficacy of Softacort (Hydrocortisone 0.335%) in chronic dry eye patients with ocular surface inflammation using two different treatment regimes.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Normal ophthalmic findings except dry eye disease
    - Ametropy ≤ 6 diopters
    - Chronic dry eye defined as longer than six months since diagnosis
    - OSDI ≥ 22
    - Conjunctival Hyperemia≥ Grade 3 (Efron Scale)
    - Current use of topical lubricants since at least 3 months
    E.4Principal exclusion criteria
    Ophthalmic exclusion criteria
    • Best far corrected visual acuity < 1/10
    • Severe Dry Eye associated with:
    - Eyelid malposition
    - Sjogren Syndrome
    - Stevens Johnson Syndrome
    - Corneal dystrophy
    - Ocular neoplasia
    - Filamentous keratitis
    - Corneal neovascularisation
    - Orbital radiotherapy
    • History of any of the following within last 3 months:
    • Systemic treatment of dry eye
    • Systemic treatment of MGD
    • Isotretinoïde,
    • Cyclosporine,
    • Tacrolimus, Siromilus, Pimecrolimus
    • Punctual plugs
    • Anti-glaucoma treatment
    • History of any of the following within previous six months:
    • ocular trauma
    • ocular infection, Ocular allergy
    • History of any of the following within last 12 months:
    • inflammatory corneal ulcer
    • Herpetic eye infection
    • or uveitis
    • Ocular surgery
    • History of IOP increase caused by systemic or topical treatment with corticosteroids
    • IOP > 22mmHg
    • Glaucoma in the medical history
    Systemic / non ophthalmic exclusion criteria:
    • Known hypersensitivity to any of the components of the IMP under investigation or other study medication
    • Allergic rhinitis; active or susceptible to reactivation during the study

    Specific exclusion criteria for women:
    • Pregnant or breast-feeding woman.
    • Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms)

    Exclusion criteria related to general conditions
    • Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
    • Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
    • Participation in another clinical study or clinical investigation at the same time as the present investigation
    • Participation to the present clinical investigation during the exclusion period of another clinical study
    • Patient already included once in this clinical investigation
    • Patient under guardianship
    E.5 End points
    E.5.1Primary end point(s)
    Patient satisfaction assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks after treatment initiation
    4 weeks after treatment initiation
    E.5.2Secondary end point(s)
    - Corneal fluorescein staining according to the Oxford Scale
    - Tear film thickness as measured with ultra-high resolution optical coherence tomography (OCT)
    - Tear Osmolarity (tearlab osmolarity test)
    - HLA-DR expression
    - Symptoms using the OSDI questionnaire
    - Patient diary for Symptoms & average frequency of artificial tears instillation for the last 3 days
    - Intraocular pressure (IOP)
    - Best corrected distance visual acuity
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 weeks after treatment initiation
    4 weeks after treatment initiation
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparison of 2 treatment regimes
    E.8.2.4Number of treatment arms in the trial2
    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
    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 months0
    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) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state60
    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 patients have ended the participation in the trial, patients will receive treatment according to the standard clinical practice for dry eye treatment.
    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 Decision2017-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-28
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