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

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
Visit 2;
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.

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 30 days before Visit 1;
15. Female subjects who are pregnant, nursing, or plan to become pregnant at
any time during the study;
16. History or current evidence of a medical condition predisposing the patient
to degenerative myopia (e.g., Marfan syndrome, Stickler syndrome) or a
condition that may affect visual function or development (e.g., diabetes
mellitus, chromosome anomaly)
17. Have a central nervous system disorder (e.g., epilepsy, cerebral disorders,
Down syndrome)
18. Have a condition or a situation, which in the Investigator*s opinion, may
put the subject at increased risk, confound study data, or interfere
significantly with the subject*s study participation, including but not limited
to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine,immunologic, dermatologic, hematologic, neurologic, or psychiatric
disease.