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

A clinical trial of STN1014100 ophthalmic solution in healthy adult male volunteers and dry eye patients for single and repeated dose - Phase I/IIa, clinical pharmacology study, exploratory study -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051220152

Enrollment

134

Registered

2023-01-18

Start date

2023-01-20

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

Dry eye

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Safety, Pharmacokinetics, Efficacy (Tear fluid secretion)	—

Contacts

Public ContactOka Koji

Santen pharmaceutical co.,ltd

clinical@santen.co.jp+81-6-4802-9341

Outcome results

None listed

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