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    Summary
    EudraCT Number:2017-004262-95
    Sponsor's Protocol Code Number:0130A01SA
    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:2018-12-19
    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 number2017-004262-95
    A.3Full title of the trial
    Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International clinical study comparing the efficacy and safety of DE-130A with Xalatan® in patients with glaucoma (high pressure inside the eye).
    A.4.1Sponsor's protocol code number0130A01SA
    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 SponsorSanten SAS
    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 supportSanten SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanten SAS
    B.5.2Functional name of contact pointRegulatory Affairs EMEA
    B.5.3 Address:
    B.5.3.1Street AddressGenavenir IV, 1 rue Pierre Fontaine
    B.5.3.2Town/ cityEvry
    B.5.3.3Post code90158
    B.5.3.4CountryFrance
    B.5.6E-mailregulatoryaffairs@santen.com
    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.3.2Product code DE-130A
    D.3.4Pharmaceutical form Eye drops, emulsion
    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 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 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 Xalatan 50 micrograms/ml eye drops, solution
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 50 micrograms/ml eye drops, solution
    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 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-Angle Glaucoma or Ocular Hypertension
    E.1.1.1Medical condition in easily understood language
    Glaucoma
    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 PT
    E.1.2Classification code 10030348
    E.1.2Term Open angle glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    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
    To demonstrate that the intraocular pressure (IOP) reducing effect of DE-130A (latanoprost 50 µg/ml preservative-free eye drops emulsion) is non-inferior to that of Xalatan® [latanoprost 50 µg/ml Benzalkonium Chloride (BAK)-preserved eye drops solution] in patients with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) at Week 12 without using any rescue medication(s).
    E.2.2Secondary objectives of the trial
    - To compare the effect on improving OSD signs and symptoms between treatment groups over 3 months (Period 1).
    - To estimate the effect of DE-130A on OSD signs and symptoms improvement up to 15 months (Periods 1 & 2).
    - To compare the efficacy on IOP reduction between treatment groups over 3 months (Period 1).
    - To estimate the effect of DE-130A on IOP up to 15 months (Periods 1 & 2).
    - To estimate the local ocular tolerance and systemic safety of the two treatments over 3 months (Period 1).
    - To estimate the local ocular tolerance and systemic safety of DE-130A up to 15 months (Periods 1 & 2).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female, 18 years of age or older
    -Diagnosis of OAG (primary open angle glaucoma, pseudo exfoliative glaucoma, or pigmentary glaucoma), or OHT in eligible eye(s) currently
    on monotherapy.
    -Unilateral OAG, or OHT are permissible as long as the physician does not anticipate significant IOP changes to the fellow eye that would require treatment during the duration of the study.
    -Current treatment with monotherapy for OAG or OHT with a controlled IOP ≤ 18 mmHg in each eye (pre-washout).
    -Stable visual field. If historical visual fields not available within the last 18 months prior to screening but, at least two OCTs are available
    including one in the last 6 months and are stable, the patient can be enrolled if a visual field test is also performed at screening and shows no
    defect or only an early visual field loss in either eye (mean deviation lesser than -6 dB).
    -Post-washout IOP ≥ 22 mmHg in at least one eye . If IOP is <22 mmHg, wash-out period can be extended, IOP should be re-assessed 2 to 3 days
    after the first measurement. If the IOP is still < 22 mmHg at the second measurement, a third assessment should be performed 2 to 3 days after the second measurement.
    -Post-washout IOP ≤ 32 mmHg in both eyes.
    E.4Principal exclusion criteria
    -Any form of glaucoma other than primary open angle glaucoma, pseudo exfoliative glaucoma, and pigmentary glaucoma in either eye.
    -IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 32 mmHg in either eye.
    -Current treatment for glaucoma with a fixed-combination therapy or more than one drug or with an oral drug within 6 months prior to screening.
    -Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer in either eye.
    -Central corneal thickness ≤ 480 μm or ≥ 600 μm in either eye (historical value or at the screening visit)
    -Significant visual field loss (absolute defect in the 10° central point or mean deviation worse than -12 dB) or progressive field loss during the year before screening.
    -Significant optic nerve abnormality, other than glaucomatous abnormalities in the opinion of the investigator as determined by ophthalmoscopy.
    -Significant changes of the optic neuropathy (e.g. increase cupping since the last examination, optic nerve hemorrhage)
    -Inability to visualize the patient's optic nerve.
    -Gonioscopy consistent with potential angle closure glaucoma.
    -Patients with severe blepharitis and/or Meibomian Gland Disease (MGD). Patients enrolled with mild to moderate blepharitis and/or MGD should be treated as appropriate during the study
    -Known hypersensitivity to sulfonamides, severe renal impairment or hyperchloraemic acidosis.
    -Any active ocular disease
    -Intraocular surgery within 6 months prior to screening.
    -Past history of any filtering surgery for glaucoma.
    -Refractive surgery of any type within 1 year prior to screening
    -Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in Intra Ocular Pressure (IOP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: The change from baseline in peak (9:00 am ± 1 hour) and trough (4:00 pm ± 1 hour) IOPs, respectively, at Week 12 between the two treatment groups in the study eye.
    E.5.2Secondary end point(s)
    The key secondary endpoints are:
    •Change in Corneal Fluorescein Staining (CFS) in the study eye in patients with baseline CFS ≥ 1.
    •Change in OSD symptom score in the study eye in patients with baseline symptom average score>0
    Safety and Tolerability:
    •The incidence and severity of ocular and systemic adverse events
    •Best-corrected distance visual acuity (BCDVA)
    •Slit lamp examination (lashes, anterior chamber and lens).
    •Dilated and undilated (cup-to-disc ratio) fundoscopy
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Change from baseline in CFS score at Week 12 with baseline CFS ≥ 1
    •Change from baseline in OSD symptom score (average of 3 symptoms) at Week 12 with baseline symptom average score>0
    Safety and Tolerability:
    At all visits and for each treatment (Period 1) and for the Open-Label population for DE-130A at all visits (Period 2 and Periods 1 & 2 combined),
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Period 1: investigator-masked; Period 2: open-label
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Korea, Republic of
    Russian Federation
    Austria
    Belgium
    Estonia
    Finland
    France
    Germany
    Italy
    Latvia
    Poland
    Spain
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial 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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 305
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 380
    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)
    None.
    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 Decision2019-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-26
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