A study of DE-127 ophthalmic solution in subjects with myopia - A Phase II/III-

A randomized, double-masked, placebo-controlled study of DE-127 ophthalmic solution in subjects with myopia - A Phase II/III, Confirmatory Study-

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224816

Enrollment

288

Registered

2019-08-01

Start date

2019-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

investigational material(s) Generic name etc : Atropine Sulfate Hydrate INN of investigational material : Atropine Sulfate Hydrate Therapeutic category code : 131 Agents for ophthalmic use Dosage and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent from legally acceptable representative and assent from subject have been obtained. - Cycloplegic objective spherical equivalent -1.0 to -6.0 D - Active myopia progression with vision acuity test

Exclusion criteria

Exclusion criteria: - Patients who previously used contact lenses and/or treatments for reducing myopia progression. - Patients who previously participated in a clinical trial of DE-127 ophthalmic solution. - Other patients who are inappropriate as participants in this study in the opinion of the investigator or subinvestigator.

Design outcomes

Primary

Measure	Time frame
efficacy The change in objective spherical equivalent	—

Secondary

Measure	Time frame
safety Adverse events	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026