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Active-Controlled, Parallel-Group Study of SJP-0170 in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

SJP-0170 Phase 3 -A Multicenter, Randomized, Single-Masked, Active-Controlled, Parallel-Group Study in Patients with Primary Open Angle Glaucoma or Ocular Hypertension(3-01 Study)-

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031240149
Enrollment
318
Registered
2024-06-27
Start date
2024-06-28
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 or Ocular hypertension

Interventions

Sponsors

Omatsu Kazunori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged 18 years or older at the time of Informed Consent (any gender) Have been diagnosed with primary open angle glaucoma or ocular hypertension Need to decrease intraocular pressure with ophthalmic solution in both eyes. Able to control intraocular pressure only by ophthalmic solution. Meet the other protocol-specified inclusion criteria

Exclusion criteria

Exclusion criteria: Have participated in other clinical trial and been administered investigational drug etc. or have a schedule of it during the period specified in protocol Have been conducted any treatment for glaucoma except for administration of ophthalmic solution during the period specified in protocol Have a history of ocular surgery/laser therapy to decrease intraocular pressure Have a history of intraocular surgery during the period specified in protocol, or a schedule of it during the study Have been conducted intraocular, sub-Tenon's, or subconjunctival injection of corticosteroid during the period specified in protocol Require to wear contact lens during the study Have active ocular disease other than primary open angle glaucoma or ocular hypertension Have severe visual field disorder Have abnormalities that interfere with measurement of intraocular pressure Have a history of corneal transplantation or corneal refractive surgery Have severe systemic illness Have a history of hypersensitivity or serious adverse reaction to any of the drugs used in the study Pregnant, lactating, or potentially pregnant. Unable to obtain a consent to practice adequate contraception during the study Unable to obtain a consent to practice adequate contraception and not to donate sperm during the study Have judged that it is inappropriate to participate in this study by investigator Meet the other protocol-specified exclusion criteria

Design outcomes

Primary

MeasureTime frame
Change in intraocular pressure from baseline

Secondary

MeasureTime frame
Efficacy and Safety

Contacts

Public Contactdivision Clinical

Senju Pharmaceutical Co., Ltd.

senju-clinicaltrials@senju.co.jp+81-78-777-1018

Outcome results

None listed

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