A phase I/IIa study of STN1014100 ophthalmic solution in healthy adult male volunteers and dry eye patients

JRCT ID: jRCT2051220152

Registered date:18/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dry eye
• Date of first enrollment: 20/01/2023
• Target sample size: 134
• Study type: Interventional

Intervention(s)

Group 1: STN1014100, 1 drop, once daily
Group 2: STN1014100 or placebo, 1 drop, twice daily
Group 3: Diquas LX 3%,1 drop, three times daily

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics, Efficacy (Tear fluid secretion)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 18 years of age or older
- Male or Female
- Both eyes diagnosed as having dry eye

Exclude criteria

- Any corneal and conjunctival abnormalities or other diseases other than dry eye affecting the ocular surface
- Having eye disease requiring treatment other than dry eye.
- Anatomically and functionally abnormal eyelids (e.g. Eyelid closure failure)
- Anyone otherwise considered unsuitable for the study by the investigators

Related Information

• Primary Sponsor: Koji Oka
• Secondary ID(s): Nil known