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    Summary
    EudraCT Number:2020-004836-93
    Sponsor's Protocol Code Number:012603SA
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-30
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-004836-93
    A.3Full title of the trial
    An Exploratory Study to Assess the 24-hour Intraocular Pressure (IOP) Lowering Characteristics, Duration of Action and Safety of DE-126 ophthalmic solution 0.002% versus Latanoprost ophthalmic solution 0.005% in Subjects with Primary Open Angle Glaucoma or Ocular Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study comparing the efficacy and safety of DE-126
    with latanoprost in patients with glaucoma (high pressure inside the eye)
    A.4.1Sponsor's protocol code number012603SA
    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 INCORPORATED
    B.1.3.4CountryUnited States
    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 Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanten Oy
    B.5.2Functional name of contact pointResponsible Physician
    B.5.3 Address:
    B.5.3.1Street AddressKarhumäentie 3,
    B.5.3.2Town/ cityVantaa,
    B.5.3.3Post code01530
    B.5.3.4CountryFinland
    B.5.4Telephone number+358405012416
    B.5.6E-mailauli.ropo@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-126
    D.3.4Pharmaceutical form Eye drops, suspension in single-dose container
    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 INNSepetaprost
    D.3.9.1CAS number 1262873-06-2
    D.3.9.2Current sponsor codeDE-126
    D.3.9.3Other descriptive nameONO-9054
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.002
    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 No
    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.3.2Product code S01EE01
    D.3.4Pharmaceutical form Ear/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.3.9.4EV 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
    Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
    E.1.1.1Medical condition in easily understood language
    Glaucoma
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036719
    E.1.2Term Primary open angle glaucoma
    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 compare the 24h IOP lowering characteristics of DE-126 ophthalmic solution 0.002% with latanoprost ophthalmic solution 0.005%, both given once daily in the evening for 3 months+1 day
    E.2.2Secondary objectives of the trial
    To compare additional characteristics of the 24h IOP efficacy of DE-126 in comparison to latanoprost

    Safety Objectives
    To assess the safety profile of DE-126 ophthalmic solution 0.002% given once daily (QD) in subjects with POAG or OHT

    Exploratory Objectives
    To explore Quality of Life in subjects with POAG or OHT when given DE-126 or latanoprost for 3 months.
    To gain experience in self-monitoring of IOP by the subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF).
    2. Be 18 years of age or older on the date of signing the ICF and be able and willing to comply with all treatment and follow-up study procedures.
    3. If a subject is a female of childbearing potential (i.e., not post-menopausal [within 12 months since the last menses] or not surgically sterile [less than 6 months from date of surgery]), she must have a negative urine pregnancy test and must use at least one of the following acceptable contraceptive methods during the study (as well as for 4 weeks following the last dose in the study).
     Abstinence
     Hormonal contraceptive method (including oral or transdermal contraceptives,
    injectable progesterone, progestin subdermal implants, progesterone-releasing
    intrauterine devices [IUDs]) initiated at least 28 days prior
     Placement of a copper-containing IUD
     Condom with spermicidal foam/gel/film/cream/suppository
    4. The male partner of the female subject of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery atleast 6 months prior to signing the study ICF and beginning screening), or other
    contraception deemed adequate by the investigator during the study.
    a . Male subjects, with a female partner of childbearing potential, should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF), or other contraception deemed adequate by the investigator during the study.
    5. Must have a diagnosis of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in both eyes or one eye with POAG and the other with OHT.
    6. BCVA of +0.60 logMAR (Snellen equivalent 20/80) or better in each eye.
    7. Central corneal thickness ≥ 480 m and ≤ 600 m in each eye.
    8. Anterior chamber angle grade ≥ 2 (Shaffer scale) in each eye.
    In addition to continuing to meet inclusion criterion 6 (BCVA), the subject must meet the following criteria at Visit 2 (Eligibility, D -2):
    9. Completed the required wait/washout period (if required per protocol).
    10. At all time points of IOP measurements (08:00, 12:00, and 16:00) at Visit 2 (Eligibility, D -2), have IOP of ≥ 22 mmHg in at least one eye (the same eye), and ≤ 34 mmHg in both eyes.
    E.4Principal exclusion criteria
    At Visit 1 (Screening) and Visit 2 (Eligibility, D -2), subjects with any of the following ocular conditions in either eye or with any of the following non-ocular conditions or characteristics are not eligible to participate in the study:
    General
    1. Females who are pregnant, nursing, or planning a pregnancy.
    2. Subjects with known or suspected drug or alcohol abuse.
    3. Participation in other investigational drugs (oral or topical therapy) or device clinical trials within 28 days prior to Visit 2 (Eligibility, D -2) and/or participation in other investigational drugs (intravitreal injection therapy) within 3 months or 5 half-lives (whichever is longer) prior to Eligibility, Day -2, or planning to participate in other investigational drug or device clinical trials during a time which would overlap with the duration of the study. This includes both ocular and non-ocular clinical trials. Exposure to investigational biologics should be discussed with the medical monitor.
    Medications / Therapies
    4. Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
    5. Subjects who will be required to initiate or modify any systemic or topical medication known to affect IOP (e.g., β-adrenergic antagonists, α-adrenergic agonists, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors, and angiotensin II receptor blockers [ARBs]). Subjects using the above medications must be on a stable dose use for at least 28 days prior to Visit 2 (Eligibility, D -2) and the duration of the study.
    6. Intended or current use of the following prohibited medications/therapies during the
    study duration:
    All ocular medications other than sodium chloride/potassium chloride ophthalmic solution, cataract treatment agents (e.g., lutathione, pirenoxine), Vitamin B12 formulation (e.g., cyanocobalamine), over-the-counter artificial tears/drops, and
    study medications.
    All systemically administered ocular hypotensive medications (e.g., oral or intravenous CAI, oral glycerol).
    Any ocular, periocular, inhaled, nasal, or systemic corticosteroids (excluding joint injections).
     Lacrimal/punctal occlusion via plug(s) or cautery.
    7. Known allergy, hypersensitivity, or contraindications to prostaglandins, or any other
    components (e.g., Benzalkonium Chloride [BAK]) of the study medications or other
    study-related procedures/medications.
    8. History of ocular surgery specifically intended to lower IOP (e.g., laser trabeculoplasty, filtering surgery, tube shunt, Minimally Invasive Glaucoma Surgery (MIGS), or trabeculotomy) in either eye. Please note that a history of laser iridotomy is allowed.
    9. History of keratorefractive surgery (e.g., radial keratotomy [RK], photorefractivekeratectomy [PRK], laser-assisted-in-situ keratomileusis [LASIK]) in either eye.
    10. Use of contact lenses within 1-2 weeks prior to Visit 2 (Eligibility, D -2) until end of treatment in either eye (1 week for soft contact lens wearers, and/or 2 weeks for rigid contact lens wearers).
    11. Any ocular surgery within 180 days prior to Visit 2 (Eligibility, D -2) and throughout the
    study in either eye.
    Diseases
    12. Presence of advanced glaucoma (e.g., visual field mean deviation worse than -12 dB) in either eye.
    13. Presence of any corneal abnormality or other conditions interfering with or preventing reliable Goldmann applanation tonometry (e.g., Fuch’s dystrophy or significant corneal surface abnormality) in either eye.
    14. Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye.
    15. History of iritis and/or uveitis, corneal inflammatory conditions, and/or viral infection, such as herpes simplex virus (HSV), in either eye; history of adenovirus infection is not an exclusion criterion if no associated inflammation has been observed within 6 months prior to the subject’s Screening Visit.
    16. Aphakia, pseudophakia with a torn posterior lens capsule, history or presence of macular edema or known risk factors (e.g., retinal vein occlusion, diabetic retinopathy, uveitis, age-related macular degeneration) for macular edema in either eye.
    17. History of severe ocular trauma in either eye.
    18. Any condition that prevents clear visualization of the fundus in either eye.
    19. History of retinal detachment, proliferative diabetic retinopathy, or any retinal disease that may be progressive during the time course of the study in either eye.
    20. Presence or history of any disease or condition that in the opinion of the study Investigator may put the subject at significant risk may confound study results or may interfere significantly with the subject’s participation in the study (e.g., recurrent corneal
    erosion syndrome, uncontrolled cardiovascular disease, etc.).
    21. Any decision by the Investigator or Medical Monitor to terminate a subject in screening
    or declare any subject ineligible for any sound medical reason.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    The IOP (mmHg) measured in the study eye (identified at the baseline visit) is the efficacy measure for this study.The IOP at each scheduled time point will be evaluated at each post-baseline visit. Besides observed IOP measurements, change and percent change from baseline in IOP at each scheduled time point as well as the change and percent change from baseline in mean diurnal IOP will also be derived and evaluated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Mean twenty-four-hour (24h) IOP in the study eye measured at Month 3 at 4h (24:00), 8h (04:00), 12h (08:00), 16h (12:00), 20h (16:00), and 24h (20:00) after the last dose given the previous night at 20:00.
    E.5.2Secondary end point(s)
    The IOP (mmHg) measured in the study eye (identified at the baseline visit) is the efficacy measure for this study. The IOP at each scheduled time point will be evaluated at each post-baseline visit. Besides observed IOP measurements, change and percent change from baseline in IOP at each scheduled time point as well as the change and percent change from baseline in mean diurnal IOP will also be derived and evaluated.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Mean 24-h (24h) IOP in the study eye measured at Week 6 at 4h (24:00), 8h (04:00), 12h (08:00), 16h (12:00), 20h (16:00), & 24h (20:00) after last dose given previous night at 20:00
    •Mean diurnal (08:00,12:00, 16:00&20:00) & nocturnal (24:00, 04:00) IOP at Week 6 &at Month 3
    •IOP at individual time points of 24h IOP curve at Week 6 &Month 3
    •Peak and trough IOPs at Week 6&Month 3
    •Fluctuation (difference between highest IOP reading minus lowest IOP reading within 24h curve) in IOP at Week 6&Month 3
    •Change from baseline for IOP at each time point at Week 6 & Month 3
    •IOP measured at 08:00 &12:00 at Week 2
    •IOP at 36h (08:00), 42h (14:00) and 48h (20:00) measured at Month 3 +1d after last dose for DE-126 given at Month 3 -1d vs 12h (08:00),18h (14:00) &24h (20:00) for latanoprost
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Last visit last patient
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 40
    F.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2021-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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