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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   43396   clinical trials with a EudraCT protocol, of which   7179   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:2020-003976-42
    Sponsor's Protocol Code Number:OT_101_001
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-12-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedIreland - HPRA
    A.2EudraCT number2020-003976-42
    A.3Full title of the trial
    A phase III, randomized, double-masked, placebo-controlled,
    parallel-group, multi-center study of the safety and efficacy of OT-101 (Atropine Sulfate 0.01%) in treating the progression of myopia in pediatric
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A large scale study to confirm and expand the information on the safety and effectiveness of atropine in treating the progression of myopia in pediatric subjects.
    A.4.1Sponsor's protocol code numberOT_101_001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04770610
    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 SponsorOcumension (Hong Kong) Limited
    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 supportOcumension (Hong Kong) Limited
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOcumension (Hong Kong) Limited
    B.5.2Functional name of contact pointOT101 Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressRoom502-1, Want Want Plaza, No. 211 Shimen Yi Road
    B.5.3.2Town/ cityJing’an District, Shanghai
    B.5.3.3Post code200041
    B.5.4Telephone number+86-21-61493868
    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 nameAtropine sulfate
    D.3.2Product code OT_101_001
    D.3.4Pharmaceutical form Eye drops, powder and solvent for 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.3.9.1CAS number 55-48-1
    D.3.9.4EV Substance CodeSUB00625MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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, powder and solvent for suspension
    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
    E.1.1.1Medical condition in easily understood language
    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 evaluate the efficacy of OT- 101 Ophthalmic Solution in treating the progression of myopia in Pediatric subjects following 3 years treatment
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of OT-101 Ophthalmic Solution in Pediatric subjects with myopia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must:
    1. A parent or legal guardian of each subject must provide written informed consent and sign theHIPAA form (or equivalent, if applicable), approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Whenever practical and appropriate per local requirements, a child’s assent should also be sought before inclusion into the study. The protocol is being conducted in various countries with varying ages for consent and is written to require informed consent procedures for minors in the EU based on national requirements, based on the latest guidelines on informed consent of minors. For subjects reaching age of consent during the study duration as per local requirements, consent must be obtained on the appropriate Participant Consent Form;
    2. Be able to comply with study requirements, attend all study visits, have ability to read and understand native language of subject, and be accompanied by a parent/legal guardian;
    3. Be between 3 - 15 years of age of either sex and any race or ethnicity at Visit 1 (Day -14 to -1);
    4. Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
    a. myopia between -1.00 D and -6.00 D, inclusive, of spherical equivalent
    b. astigmatism less than or equal to 1.50 DC
    5. Have anisometropia ≤ 1.0 D at Visit 1;
    6. Have a best-corrected distance visual acuity of (BCVA) of logarithm of the minimum angle of resolution (logMAR)
    ≤0.4 (approximately Snellen 20/50) for 3 year olds; logMAR ≤0.3 (approximately Snellen 20/40) for 4 year olds; logMAR ≤0.18 (approximately Snellen 20/30) for ≥5 year olds) in each eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart [R,1 or 2], or Lea Chart for subjects who do not know the alphabet, at Visit 1 and Visit 2;
    7. Females of childbearing potential agree to have urine pregnancy
    testing performed at screening(must be negative); must not be
    lactating; and must agree to use a medically acceptable form of birth
    control throughout the study duration (i.e., Spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner). For non-sexually active females, abstinence will be considered an acceptable form of birth control. Females of childbearing potential include all females who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
    8. Be able and willing to avoid all disallowed medications for the appropriate washout period between screening and randomization and during the study without significant risk to the subject.
    E.4Principal exclusion criteria
    Subjects must not:
    1. Have known contraindications or sensitivity to atropine, the study medications, or their components;
    2. Have clinically significant abnormal findings on slit lamp biomicroscopy exam (e.g., cataract) which may impact best corrected visual acuity measures in either eye at screening or a known history of a clinically significant slit lamps findings in either eye;
    3. Have clinically significant abnormal findings on indirect dilated fundoscopy exam in either eye at screening or a known history of a clinically significant retinal findings in either eye;
    4. Have any evidence of an eye movement disorder or restriction of extraocular movement (e.g.,nystagmus);
    5. Have an active ocular infection (i.e., bacterial, viral, or fungal);
    6. Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;
    7. Have a history of ocular herpetic infection, iritis, scleritis, or uveitis, whether active or inactive at screening;
    8. Have undergone any myopia control treatment including atropine, orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed;
    9. Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub-epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;
    10. Have intraocular pressure (IOP) that is < 9 millimeters of mercury (mmHg) or > 21 mmHg in either eye, or have a prior diagnosis of ocular hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication;
    11. Have had surgical intervention (ocular or systemic) within 6 months prior to Visit 1, or planned surgical intervention during the study;
    12. Use any of the following disallowed medications or therapies by any route of administration during the 2 weeks (14 days) prior to Visit 2 (Day 1):
    a. any prescription or over the counter ophthalmic products (Use of preservative-free artificial tears is allowed but may not be used within 2 hours of administration of study medication. Use of lubricating ointment form of artificial tears before bedtime is allowed but must be used at least 15 minutes after administration of study medication.)
    b. monoamine oxidase inhibitors
    c. atropine, pirenzepine, or other anti-muscarinic agent
    d. any medication affecting the pupil or accommodation
    e. orthoK, rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression. In addition, Groups b – e above are not allowed for the duration of the study.
    13. The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. Intranasal, inhaled, topical dermatologic, intra-articular, perianal steroids, and short-term oral steroids (< 2 weeks) are permitted´╝Ť
    14. Participation in any other study of investigational therapy during the study period or within 30days before Visit 1;
    15. Female subjects who are pregnant, nursing, or plan to become pregnant at any time during the study;
    16. History or current evidence of a medical condition predisposing the patient to degenerative myopia (e.g., Marfan syndrome, Stickler syndrome) or a condition that may affect visual function or development (e.g., diabetes mellitus, chromosome anomaly)
    17. Have a central nervous system disorder (e.g., epilepsy, cerebral disorders, Down syndrome)
    18. Have a condition or a situation, which in the Investigator’s opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject’s study participation, including but not limited to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of study eyes with a -0.75D of progressive myopia at Month 36 defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 36
    E.5.2Secondary end point(s)
    Change from baseline to Month 36 in study eye spherical equivalent (D) as assessed by cycloplegic autorefraction. Change from baseline to Month 36 in study eye axial length as measured by cycloplegic biometry (a device will be selected and the same device to be used throughout the duration of this study)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 36
    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. 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 169
    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) Yes
    F. of subjects for this age range: 339
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 339
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 678
    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)
    Patients will not be treated after the-study period
    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 Decision2021-12-23
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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