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    Summary
    EudraCT Number:2021-003794-56
    Sponsor's Protocol Code Number:35RC21_8901_CRYSTAL
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-09-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-003794-56
    A.3Full title of the trial
    COMPARISON OF TOPICAL HYDROCORTISONE VERSUS DEXAMETHASONE TREATMENT FOR INFLAMMATORY SECRETIONS OF THE CONJUNCTIVA IN PATIENTS WITH OCULAR PROSTHESIS
    COMPARAISON DU TRAITEMENT TOPIQUE PAR HYDROCORTISONE VERSUS DEXAMETHASONE POUR TRAITER LES SECRETIONS INFLAMMATOIRES DE LA CONJONCTIVE CHEZ LES PATIENTS PORTEURS D’UNE PROTHESE OCULAIRE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARISON OF HYDROCORTISONE EYE DROPS VERSUS DEXAMETHASONE EYE DROPS FOR THE TREATMENT OF INFLAMMATORY CONJUNCTIVAL SECRETIONS IN PATIENTS WITH OCULAR PROSTHESIS
    COMPARAISON DU TRAITEMENT PAR COLLYRE AVEC HYDROCORTISONE VERSUS COLLYRE AVEC DEXAMETHASONE POUR TRAITER LES SECRETIONS INFLAMMATOIRES DE LA CONJONCTIVE CHEZ LES PATIENTS PORTEURS D’UNE PROTHESE OCULAIRE
    A.3.2Name or abbreviated title of the trial where available
    CRYSTAL
    CRYSTAL
    A.4.1Sponsor's protocol code number35RC21_8901_CRYSTAL
    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 SponsorRENNES University Hospital
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportTHEA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRENNES University Hospital
    B.5.2Functional name of contact pointMOURIAUX
    B.5.3 Address:
    B.5.3.1Street Address2 RUE HENRI LE GUILLOUX
    B.5.3.2Town/ cityRENNES
    B.5.3.3Post code35000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033299289036
    B.5.5Fax number0033299289036
    B.5.6E-mailfrederic.mouriaux@chu-rennes.fr
    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 Dexafree
    D.2.1.1.2Name of the Marketing Authorisation holderDEXAFREE 1 mg/ml, collyre en solution en récipient unidose
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Ear/eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSOFTACORT 3,35 mg/ml, collyre en solution en récipient unidose
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Ear/eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    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: 3
    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 DULCILARMES
    D.2.1.1.2Name of the Marketing Authorisation holderDULCILARMES 1,5%, collyre en solution en récipient unidose
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Ear/eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    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
    Conjunctival, Conjunctival inflammation, Corticosteroids, Inflammation, Prosthesis
    Conjonctif, Inflammation conjonctivale, corticostéroïdes, Inflammation, prothèse
    E.1.1.1Medical condition in easily understood language
    irritation, interior of the eyelid, ocular prosthesis
    irritation, intérieur de la paupière, prothèse oculaire
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 study the efficacy of two topical molecules on the secretions of patients with prosthesis: Hydrocortisone and Dexamethasone versus a tear substitute, Dulcilarmes®, which will serve as a comparator
    Etudier l’efficacité de deux molécules topiques sur les sécrétions des patients porteurs de prothèses : l’Hydrocortisone et la Dexaméthasone versus un substitut lacrymal, le Dulcilarmes®, qui servira de comparateur.
    E.2.2Secondary objectives of the trial
    To assess the effect of treatments on :
    1) conjunctival inflammation
    2) secretions
    3) quality of life
    Evaluer l'effet des traitements sur :
    1) l’inflammation conjonctivale
    2) les sécrétions
    3) la qualité de vie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient aged 18 years or older;
    - Wearing a permanent prosthesis for more than 6 months; - Consultant in the ophthalmology department;
    - Modified OSDI score ≥ 20 points out of 40 ;
    - Affiliated to a health insurance scheme,
    - For women of childbearing potential: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate of <1%, for the duration of the study and up to 1 week after the last dose administered)
    - Having given free, informed and written consent.
    - Patient âgé de 18 ans ou plus ;
    - Porteur d’une prothèse définitive depuis plus de 6 mois - Consultant dans le service d’ophtalmologie ;
    - Score OSDI modifié ≥ 20 points sur 40 ;
    - Affilié à un système d’assurance maladie,
    - Pour les femmes en âge de procréer : contraception efficace (la contraception efficace comprend la contraception orale, les dispositifs intra-utérins et d'autres formes de contraception avec un taux d'échec <1%, pendant la durée de l'étude et jusqu'à 1 semaine après la dernière dose administrée)
    - Ayant donné un consentement libre, éclairé et par écrit.
    E.4Principal exclusion criteria
    - Treatment with eye drops (other than artificial tears or antiseptic) < 1 month;
    - Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs,
    - Known contraindications to study treatments;
    - Fatty dermal graft or complicated cavity;
    - Gougerot-Sjögren syndrome;
    - Allergic conjunctivitis;
    - Damaged prosthesis;
    - Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability);
    - Pregnant or breastfeeding woman;
    - Person already included in a RIPH1 research protocol with topical treatment of the cavity or systemic anti-inflammatory treatment and/or who could lead to a bias in the present study
    - Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.
    - Traitement par collyre(s) (autres que larmes artificielles ou antiseptique)< 1 mois ;
    - Traitement concomitant par inhibiteurs du CYP3A incluant des médicaments contenant du cobicistat,
    - Contre-indications connues aux traitements à l’étude;
    - Greffe dermo-graisseuse ou cavité compliquée ;
    - Syndrome de Gougerot-Sjögren ;
    - Conjonctivite allergique ;
    - Prothèse abimée ;
    - Impossibilité de réalisation des différents tests demandés par le protocole quel qu’en soit la raison (trouble de la compréhension, handicap moteur) ;
    - Femme enceinte ou allaitante ;
    - Personne déjà incluse dans un protocole de recherche RIPH1 avec traitement topique sur sa cavité ou anti-inflammatoire par voie générale et/ou qui pourrait entrainer un biais dans la présente étude
    - Personne faisant l'objet d'une protection légale (sauvegarde de justice, curatelle, tutelle) ou personne privée de liberté.


    E.5 End points
    E.5.1Primary end point(s)
    Secretion Self-Rating Scale score. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. (Jacobs et al.; Maucourant et al.)
    Score de l’échelle analogique d’auto-évaluation des sécrétions. Ce score noté sur 40 points est calculé en faisant la somme de 4 critères notés chacun sur 10 points. (Jacobs et al. ; Maucourant et al.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After each treatment sequence
    Après chaque séquence de traitement
    E.5.2Secondary end point(s)
    1) Bulbar conjunctival inflammation score and tarsal conjunctival inflammation score according to the grades of Saini et al.
    2)
    - Secretion frequency (score out of 10) according to the secretion analysis scale (Jacobs et al.)
    - Colour of secretions (score out of 10) according to the secretion analysis scale (Jacobs et al.)
    - Amount of secretions (score out of 10) according to the secretion analysis scale (Jacobs et al.)
    - Thickness/Viscosity of secretions (score out of 10) according to the secretion analysis scale (Jacobs et al.)
    3) OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)
    1) Scores de l’inflammation de la conjonctive bulbaire et score de l’inflammation conjonctivale tarsale selon les grades de Saini et al.
    2)
    - Fréquence des sécrétions (score sur 10) selon l’échelle d’analyse des sécrétions (Jacobs et al.)
    - Couleur des sécrétions (score sur 10) selon l’échelle d’analyse des sécrétions (Jacobs et al.)
    - Quantité des sécrétions (score sur 10) selon l’échelle d’analyse des sécrétions (Jacobs et al.)
    - Epaisseur/Viscosité des sécrétions (score sur 10) selon l’échelle d’analyse des sécrétions (Jacobs et al.)
    3) Score de qualité de vie par l’OSDI adapté aux porteurs de prothèses, noté sur 40 points (10 items avec 4 points maximum par item) (Maucourant et al.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After each treatment sequence
    Après chaque séquence de traitement
    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 No
    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 No
    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 No
    E.8.1.6Cross over Yes
    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 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 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
    LVLS
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    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)
    The choice of treatment after the trial is left to the free decision of the investigator following the patient
    le choix du traitement après l'essai est laissé à la libre décision du médecin qui suit le patient
    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 Decision2022-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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