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%

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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
at
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
surgery.
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
lenses, or
progressive addition spectacle lenses. The only allowable prior treatments are
myopic
correction in the form of single-vision eyeglasses and/or single-vision or
toric soft contact
lenses.
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
study.
18. Employees of the study site and their family members are not permitted to
participate as
subjects in the study. Immediate family is defined as a spouse, parent, child,
or sibling,
whether biological or legally adopted.
19. Current or history of significant or severe damage to the cornea.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The between-treatment group difference in proportion of subjects who show <<br /><br>-0.50 D myopia progression (SER) at the Month 36 visit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Between- treatment group difference in mean change from baseline in SER at<br /><br>the Month 36 visit.<br /><br>2. Between-treatment group difference in the proportion of subjects who show<br /><br><-0.5 D myopia progression (SER) from baseline at the month 36 visit.</p><br>