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% - CHAMP

evakar Inc.0 个研究点目标入组 483 人开始时间: 2018年9月17日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•1. Children (male or female) aged 3 to < or = 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 483
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. If present, astigmatism more than -1.50 in either eye
•2. Current or history of amblyopia or manifest strabismus.
•3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
•4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
•5. Serious systemic illness that, in the Investigator’s opinion, would render the subject ineligible.
•6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over-the-counter) other than the assigned study medication.

发起方

evakar Inc.