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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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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    EudraCT Number:2022-002158-15
    Sponsor's Protocol Code Number:SYL1001_V
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-002158-15
    A.3Full title of the trial
    Tivanisiran for Dry Eye in Subjects with Sjögren’s Syndrome
    Tivanisirán para el ojo seco en sujetos con síndrome de Sjögren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with tivanisiran for the dry eye in patients witht Sjögren Syndrome
    Tratamiento con tivanisirán para el ojo seco en pacientes con Síndrome de Sjögren
    A.4.1Sponsor's protocol code numberSYL1001_V
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04819269
    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 SponsorSylentis SAU
    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 supportSylentis SAU
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSylentis SAU
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressSantiago Grisolía nº 2
    B.5.3.2Town/ cityTres Cantos - Madrid
    B.5.3.3Post code28760
    B.5.4Telephone number+34918047667
    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 nameTivanisiran
    D.3.2Product code SYL1001
    D.3.4Pharmaceutical form Eye drops, solution
    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 INNTivanisiran
    D.3.9.2Current sponsor codeSYL1001
    D.3.9.4EV Substance CodeSUB217122
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.25
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    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
    Dry Eye Disease
    Enfermedad de Ojo Seco
    E.1.1.1Medical condition in easily understood language
    Ocular dryness
    Sequedad ocular
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10013774
    E.1.2Term Dry eye
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of tivanisiran sodium ophthalmic solution (1.125%) administered as 1 drop OU once a day in treating dry eye disease signs and symptoms in subjects with a documented diagnosis of dry eye associated with Sjögren’s Syndrome.
    Evaluar la eficacia del colirio en solución de tivanisirán sódico (11.25 mg/m) administrado en 1 gota OU una vez al día para el tratamiento de los signos y síntomas de la Enfermedad de Ojo Seco (EOS) en sujetos con un diagnóstico documentado de Ojo Seco asociado al Síndrome de Sjögren.
    E.2.2Secondary objectives of the trial
    Evaluate the safety of tivanisiran sodium ophthalmic solution (1.125%) administered as 1 drop OU QD in treating DED signs and symptoms in subjects with a documented diagnosis of dry eye associated with Sjögren’s Syndrome.
    Evaluar la seguridad del colirio en solución de tivanisiran sódico 11.25 mg/ml administrado 1 gota OU una vez al día para el tratamiento de los signos y síntomas de la EOS en sujetos con un diagnóstico documentado de Ojo Seco asociado al Síndrome de Sjögren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is a male or a female aged ≥ 18 years
    - Have given their written consent to participate in the study
    - Use of artificial tears, autologous serum or specific dry eye medications during the last 6 months.
    - Willing to not use AT or autologous serum for the study duration.
    - VAS scale for Dry Eye Symptom Score ≥40.
    - Total CFS using ≥ 5
    - Schirmer’s test with anesthesia < 10 mm/5min
    - Diagnosed with Sjögren’s Syndrome
    - Ambos sexos con edad ≥ 18 años
    - Que hayan firmado el consentimiento informado.
    - Uso de lagrimas artificiales, suero autólogo o medicación específica para el ojo seco durante los últimos 6 meses.
    - Dispuesto a no utilizar lagrimas artificiales o suero autólogo durante todo el estudio.
    - Escala VAS para la puntuación de los síntomas del ojo seco ≥40.
    - Tinción corneal total con fluoresceína (CFS) ≥ 5.
    - Diagnóstico de Síndrome de Sjögren
    E.4Principal exclusion criteria
    - Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study
    - Use of contact lenses during the study
    - Significant Eye diseases according to investigator's opinion
    - Cualquier medicación concomitante o procedimiento o cirugía ocular previo o alteración de la dosis de medicamentos sistémicos en el momento de la entrada en el estudio
    - Uso de lentillas durante el estudio.
    - Cualquier otra enfermedad ocular que sea significativa a juicio del Investigador.
    E.5 End points
    E.5.1Primary end point(s)
    1. Mean change from Baseline to Day 85 in Corneal Fluorescein Staining (CFS) total score [0-3 scale]
    2. Mean change from Baseline to Day 85 in Dry Eye Symptom Score (0-100 scale).
    1. Cambio medio desde el inicio hasta el día 85 en la puntuación total de la tinción corneal con fluoresceína (CFS).
    2. Cambio medio desde el inicio hasta el día 85 en la puntuación de síntomas de ojo seco (escala de 0 a 100).
    E.5.1.1Timepoint(s) of evaluation of this end point
    85 days
    85 días
    E.5.2Secondary end point(s)
    - Mean change from Baseline to Day 29, Day 57 and Day 85 in Corneal Fluorescein Staining (CFS) central region score
    - Mean change from Baseline to Day 85 in Corneal Fluorescein Staining (CFS) in the most severe region
    - Cambio medio desde el inicio hasta el día 29, 57 y 85 en la puntuación de la tinción corneal con fluoresceína (CFS) en la región central
    - Cambio medio desde el inicio hasta el día 85 en la puntuación de la tinción corneal con fluoresceína (CFS) en la región más afectada
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 29, 57 y 85
    Días 29, 57 y 85
    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. 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.8.2.4Number of treatment arms in the trial2
    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 concerned8
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 200
    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)
    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 Decision2022-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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