NL-OMON51907撤回3 期
A phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine Sulfate 0.01%) in treating the progression of myopia in pediatric subjects - Dolphin Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 15（—）
入选标准
- •Subjects must:
- •1. A parent or legal guardian of each subject must provide written informed
- •consent and sign the HIPAA 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;
- •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) of:
- •a) myopia between -1.00D and -6.00 D, inclusive of spherical equivalent
- •b) astigmatism less than or equal to 1.50 DC
- •5. Have anisometropia * 1.0D of spherical equivalent 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
- •7. Be able and willing to avoid all prohibited medications during the washout
- •period between screening and randomization and during the study without
- •significant risk to the subject.
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)
- 另有 2 项未显示
研究者
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