NL-OMON55813已完成3 期
Childhood Atropine for Myopia Progression (CHAMP): A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of Atropine Sulfate Ophthalmic Solution 0.01% and 0.02% - Childhood Atropine for Myopia Progression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Vyluma Inc.
- 入组人数
- 40
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 11（—）
入选标准
- •1. Children (male or female) aged 3 to <= 17.0 years.
- •2. Myopia SER of at least -0.50 D and no greater than -6.00 D myopia in each
- •eye as measured
- •by cycloplegic autorefraction.
- •3. If present, astigmatism of no more than -1.50 D in each eye as measured by
- •cycloplegic
- •autorefraction.
- •4. Anisometropia SER of < 1.50 D as measured by cycloplegic autorefraction.
- •5. Normal intraocular pressure of < 21 mm Hg in each eye.
- •6. Distance vision correctable to at least 0.1 logMAR or 20/25 Snellen
- •equivalent in each eye.
- •7. Female subjects of childbearing potential (post menarche) must have a
- •negative urine
- •pregnancy test at screening.
- •8. Subject*s parent or legal guardian must provide informed consent on behalf
- •of the subject, and
- •the subject should provide assent when applicable, per Institutional Review
- •Board (IRB)/Ethic
- •Committee (EC) guidelines. If a subject becomes an adult (depending on country
- •regulations)
- •during the study, they will need to sign an informed consent form to continue
- •in the study
排除标准
- •1. Allergy to atropine or any of the excipients of the eye drops.
- •2. Current or history of amblyopia or manifest strabismus including
- •intermittent tropia.
- •3. Heart rate is persistently (for more than 10 minutes) > 120 beats per minute
- •screening/baseline.
- •4. History of any disease or syndrome that predisposes the subject to severe
- •myopia (e.g., Marfan
- •syndrome, Stickler syndrome, retinopathy of prematurity).
- •5. History in either eye of abnormal ocular refractive anatomy (e.g.,
- •keratoconus, lenticonus,
- •spherophakia).
- •6. History in either eye of previous intraocular or ocular laser/non-laser
- •7. Current or history of glaucoma; anatomic narrow anterior chamber angles.
- •8. Serious systemic illness that, in the Investigator*s opinion, would render
- •the subject ineligible
- •9. Chronic use of any topical or systemic antimuscarinic/anticholinergic
- •medications (e.g.,
- •atropine, scopolamine, tropicamide) within 21 days prior to screening, and/or
- •anticipated need
- •for chronic use during the study period (i.e., more than 7 consecutive days in
- •1 month or more
- •than 30 total days in 1 year). (Use of cycloplegic drops for dilated ocular
- •exam are allowable.)
- •10. Chronic use (more than 3 days per week) of any topical ophthalmic
- •medications (prescribed or
- •over-the-counter) other than the assigned study medication. Use of artificial
- •tears is allowed
- •but may not be used within 2 hours of administration of study medication.
- •11. 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 (i.e., < 2 weeks) are permitted.
- •12. Prior myopia control treatment including orthokeratology, bifocal contact
- •progressive addition spectacle lenses. The only allowable prior treatments are
- •correction in the form of single-vision eyeglasses and/or single-vision or
- •toric soft contact
- •13. Preplanned hospitalization during the study period.
- •14. Unwilling or unable to complete study procedures or to be followed up for
- •the 48-month
- •duration of the study.
- •15. Participation in any other study of investigational therapy during the
- •study period or within the
- •last 30 days.
- •16. History of any substance abuse (excessive or habitual use of alcohol and/or
- •drug including
- •nicotine) and not willing to abstain from these substance(s) during the 4-year
- •study period.
- •17. Female subjects who are pregnant, nursing, or plan to become pregnant at
- •any time during the
- 另有 6 项未显示
研究者
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