K-115 phase 3 add-on study with timolol

Phase 3 confirmatory study of K-115 added to timolol 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-jRCT2080221659

Enrollment

200

Registered

2011-11-29

Start date

2011-11-29

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. IOP after timolol run-in period >= 18mmHg

Exclusion criteria

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