DE-117B Biological equivalence study

Biological equivalence study of 0.002% DE-117B Ophthalmic Solution and 0.002% Omidenepag Isopropyl Ophthalmic Solution in Subjects with Primary Open Angle Glaucoma or Ocular Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225126

Enrollment

Registered

2020-03-16

Start date

2020-03-11

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

Primary Open Angle Glaucoma, Ocular Hypertension

Interventions

investigational material(s) Generic name etc : Omidenepag Isopropyl INN of investigational material : Omidenepag Isopropyl Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Must have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT. - Corrected visual acuity (CVA) of 0.2 or better in each eye.

Exclusion criteria

Exclusion criteria: - Females who are pregnant, nursing or planning a pregnancy. - Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period. - Use of contact lenses within 2-3 weeks prior to Baseline until end of treatment in either eye - Aphakia or pseudophakia in either eye

Design outcomes

Primary

Measure	Time frame
bioequivalence Mean diurnal IOP at Week 4 visit	—

Secondary

Measure	Time frame
bioequivalence Mean diurnal IOP at Week 1 visit	—

Countries

Japan

Outcome results

None listed

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