K-115 phase 3 comparative study

Phase 3 confirmatory study of K-115 versus placebo in patients with primary open-angle glaucoma (POAG) and ocular hypertension (OH)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221524

Enrollment

100

Registered

2011-07-29

Start date

2011-07-29

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

POAG or OH

Interventions

investigational material(s) Generic name etc : K-115 INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. POAG or OH patients 2. Untreated IOP >= 21mmHg

Exclusion criteria

Exclusion criteria: 1.Patients whose visual acuity is below 0.3 2.Patients thought to use glaucoma medication 3.Patients thought to wear contact lenses etc.

Design outcomes

Primary

Measure	Time frame
Efficacy :IOP Safety :Adverse event (AE) and adverse drug reaction (ADR) Efficacy :IOP lowering effect at 4, 6 and 8 weeks Safety :Incidence of AE and ADR	—

Secondary

Measure	Time frame
Efficacy :IOP Safety :Ophthalmologic examination, etc Efficacy :IOP lowering effect at 2, 4, 6 and 8 weeks Safety :Change from baseline in ophthalmologic examination at 8 weeks, etc	—

Outcome results

None listed

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