A Phase 2a Study assessing the efficacy and safety of STN1013400 ophthalmic solution in patients with myopia

JRCT ID: jRCT2031230110

Registered date:03/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Myopia
• Date of first enrollment: 22/05/2023
• Target sample size: 67
• Study type: Interventional
• Intervention(s): High dose STN1013400 ophthalmic solution, low dose STN1013400 ophthalmic solution or placebo

Outcome(s)

• Primary Outcome: The change in objective spherical equivalent

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 11age old
• Gender: Both

Include 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 (-1.0 <=X<= -6.0) in both eyes.
Patients with progressive myopia on refractive examination.

Exclude criteria

Patients who previously receive treatments for reducing myopia progression.
Patients who are inappropriate as participants in this study in the opinion of the investigator or sub-investigator.

Related Information

• Primary Sponsor: Migita Yukie