EUCTR2020-003976-42-IE进行中（未招募）1 期
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 pediatricsubjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 678
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. UK, Hungary, Poland, Ireland, Slovakia, Spain: 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. Ireland, Slovakia, Spain, US, China: 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 169
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •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;
- •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 an
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