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    Summary
    EudraCT Number:2019-001642-18
    Sponsor's Protocol Code Number:WP3
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-11-21
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001642-18
    A.3Full title of the trial
    Effect on the ocular surface when treating glaucoma with eye drops: an investigation of the conjunctival goblet cells
    Påvirkningen af øjets overflade ved behandling af glaukom: en undersøgelse af de konjunktivale bægerceller
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect on the eye surface when treating glaucoma with eye drops
    Effekt på øjets overflade ved behandling af grøn stær med øjendråber
    A.4.1Sponsor's protocol code numberWP3
    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 SponsorDepartment of Ophthalmology, Rigshospitalet-Glostrup
    B.1.3.4CountryDenmark
    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 supportDepartment of Ophthalmology, Rigshospitalet-Glostrup
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Drug Design and Pharmacology, University of Copenhagen
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressJagtvej 160
    B.5.3.2Town/ cityCopenhagen E
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004522334504
    B.5.6E-mailanne.hedengran.nagstrup@regionh.dk
    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 Monoprost
    D.2.1.1.2Name of the Marketing Authorisation holderThea
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameMonoprost
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLatanoprost
    D.3.9.3Other descriptive nameLATANOPROST
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Xalatan
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameXalatan
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLatanoprost
    D.3.9.3Other descriptive nameLATANOPROST
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Open angular glaucoma and ocular hypertension
    E.1.1.1Medical condition in easily understood language
    glaucoma and ocular hypertension
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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 compare goblet cell density when treating with a differently preserved travoprost eye drops in each eye
    E.2.2Secondary objectives of the trial
    To compare eye pressure, ocular surface, tear film and symptoms of dry eyes when treating with a differently preserved travoprost eye drops in each eye
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. General criteria
    a. age ≥18 years
    b. danish speaking
    b. OHT or POAG
    c. Average IOP ≥ 22 mmHg after washout based on three measurements on each eye
    a. Generelle kriterier
    a. Alder ≥18 år
    b. Dansktalende
    b. OHT eller POAG
    c. Gennemsnitteligt tryk≥ 22 mmHg efter udvaskning udfra 3 målinger på hvert øje.
    E.4Principal exclusion criteria
    a. History with significnat treatment required eye disease (including trauma) other than POAG or OHT
    b. Ocular surface disease based on fluorescein staining at inklusion
    c. Need for multidrug glaucoma treatment
    d. > 4 mmHg difference in IOP between eyes
    e. Corneal thickness <450 µm or >600 µm
    f. Treatment with systemic or lokal steroid within 3 months of study start
    g. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune disease. Diseases are acceptable if well-treated or if no treatment is required.
    h. Smoking at inklusion
    i. Pregnant or nursing. Pregnancy test will be performed on fertile women at inklusion.
    j. Women not using safe contraception. The following contraception is accepted and shall be used under the entire study period: IUD or hormonal contraception (pill, implant, transdermal bandaid, vaginal ring or injektion). Sterile and non-fertile women do not need to use contraception. To be considered non-fertile or sterile a woman must be sterilized through surgery (Bilateral Tubal Ligation, hysterectomy or bilateral ovariectomy) or be postmenopausal (defined as at least 12 months since last period before inklusion). After completing the study there will be no need to follow up on fertile women regarding potential pregnancy as the study medication has poor systemic absorption and does not have a teratogen effect.
    k. Known allergy towards active drug or additives in study medication.
    l. Patients unable to coorperate.
    a. Anamnese med betydende behandlingskrævende øjensygdom (inklusiv okulært traume) anden end glaukom og okulær hypertension
    b. Okulære overfladesygdomme ved fluorescein farvning ved inklusion
    c. Behov for flerstofsbehandling af glaukom
    d. Mere en 4 mmHg forskel mellem øjnene
    e. Corneatykkelse målt med pachymeter <450 µm eller >600 µm
    f. Behandling med systemisk eller lokalt binyrebarkhormon seponeret indenfor 3 mdr. fra forsøgsstart.
    g. Personer med betydende ubehandlet systemiske sygdomme fx hypertension, hjertesvigt, diabetes mellitus, tidligere cerebralt infarkt eller blødning, lungesygdomme samt autoimmune sygdomme. Sygdommene accepteres såfremt, de er velbehandlede eller ikke er behandlingskrævende
    h. Ryger på inklusionstidspunktet
    i. Gravide eller ammende. Graviditetstest udføres på fertile kvinder inden inklusion.
    j. Kvinder der ikke bruger sikker prævention. Følgende svangerskabsforebyggende midler anses som sikker antikonception, og skal bruges under hele forsøgsperioden: Spiral eller hormonel antikonception (p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion). Sterile eller ikke fertile forsøgsdeltagere er fritaget for kravet om brug af antikonception. For at betragtes som steril eller ikke fertil, må man almindeligvis være kirurgisk steriliseret (vasektomi/bilateral tubektomi, hysterektomi og bilateral ovarektomi) eller være postmenopausal, defineret som udebleven menstruation i mindst 12 måneder før studie indrullering. Efter afslutning af forsøget er der ikke behov for at følge fertile kvinder mhp. graviditet, da forsøgsmedicinens systemiske optag er ringe og ikke anses for at være teratogent.
    k. Personer med allergi overfor indholdsstofferne i medicin, der gives under forsøget
    l. Forsøgspersoner, der ikke kan samarbejde til undersøgelse
    E.5 End points
    E.5.1Primary end point(s)
    Goblet cell density
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    E.5.2Secondary end point(s)
    Intraocular pressure lowering effect
    Corneal and conjunctival surface
    Mucin in tear film
    Symptoms of dry eyes
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    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) Yes
    E.8.2.2Placebo No
    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 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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state28
    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)
    Correct treatment to lower pressure to acceptable levels with prostaglandin analogues, beta-blockers, carbonoic anhydroic inhibitors or alpha adrenergic agonists
    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 Decision2019-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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