A multicenter, randomized, double masked, controlled by vehicle, to assess safety and the efficacy of the ophthalmic solution, SYD-101, for the treatment of Myopia in Childre

Phase 1

Conditions: Myopia
MedDRA version: 20.0Level: PTClassification code 10028651Term: MyopiaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2018-004775-13-AT

Lead Sponsor: Sydnexis, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 840

Inclusion Criteria

Participants must meet all of the inclusion criteria to be included in the study:
1. Parent/guardian has the ability to understand the study informed consent form (ICF) and agrees to sign the ICF prior to initiation of any protocol-related procedures; participant has the ability to give assent, as applicable, at the time of parental/guardian consent.
2. Participant is male or female between 3 and 14 years of age (inclusive) at the time of Screening.
3. Participant and parent/guardian are willing and able to comply with study instructions, study visits, and procedures.
4. Participant (or parent/guardian) has demonstrated ability to administer artificial eyedrops at the Screening or Baseline visit.
5. Participant is in good general health, with no clinically significant findings based on medical history and vital signs, as determined by the investigator at the time of Screening.
6. Postmenarchal female participants must have negative urine pregnancy test results.
The following inclusion criteria (#7 through #11) are required of both eyes:
7. Refractive error by cycloplegic autorefraction at the baseline visit:
a) Myopia of 0.50 D to 6.00 D (inclusive)
b) Astigmatism =1.50 D
c) Anisometropia =1.00 D
8. If the baseline myopia (SE) is <0.75 D, participant must have a history of myopia progression of 0.50 D in the previous 6 to 12 months.
9. If baseline myopia (SE) is =0.75 D, participant must be wearing refractive correction (single vision eyeglasses or soft, daily-wear, single-vision contact lenses) that meets the following criteria:
a) Myopia (SE) corrected to within ±0.50 D of the investigator’s cycloplegic measurement of refractive error.
b) Cylinder power must be within ±0.50 D of the investigator’s standard refraction technique, which can be based on a cycloplegic or non-cycloplegic refraction.
c) Cylinder axis must be within ±5 degrees of the axis found on the investigator’s standard refraction when cylinder power is =1.00 D or within ±15 degrees when the cylinder power is <1.00 D.
10. BCVA of 75 letters (Snellen equivalent 20/32) or better.
11. Normal IOP <21 mmHg.
Are the trial subjects under 18? yes
Number of subjects for this age range: 840
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

Exclusion Criteria

Participants who meet any of the exclusion criteria will be excluded from the study:
1. Participant is a female who is pregnant, lactating, or intending to become pregnant within next 4 years.
2. Participant has a known allergy or hypersensitivity to atropine or any of the components of SYD-101.
3. Participant has history or current evidence of a medical condition predisposing the participant to degenerative myopia (eg, Marfan syndrome, Stickler syndrome) or a condition that may affect visual function or development (eg, diabetes mellitus, chromosome anomaly).
4. One or more biological parents with a history of myopia =9.00 D
5. Current use of a monoamine oxidase inhibitor
6. History of, or currently receiving treatment for, any systemic infection or autoimmune disease considered serious by the investigator
7. Participation in an investigational drug or device study within 30 days prior to Screening
8. Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis
9. History or evidence of the following in either eye:
a) Retinopathy of prematurity
b) Abnormal refractive anatomy (eg, keratoconus, lenticonus, spherophakia)
c) Amblyopia, manifest strabismus, or nystagmus
10. Use of any of the following (previously, currently, or plans to do so in the future):
a) Orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression.
b) Use of atropine, pirenzepine, or other anti-muscarinic agent for myopia
11. History or evidence of any ocular surgery or planned future ocular surgery in either eye
12. History or current evidence of ocular disease in the either eye that, in the opinion of the investigator, may confound assessment of visual acuity and/or refraction
13. Unwillingness or inability to comply with study requirements and restrictions, including but not limited to those specified in Section 5.3 (eg, required conversion from extended wear lenses to daily wear lenses, full-time use of contact lenses or spectacles)