臨床研究等提出・公開システム

SJP-0170 Phase 3 -A Multicenter, Randomized, Single-Masked, Active-Controlled, Parallel-Group Study in Patients with Primary Open Angle Glaucoma or Ocular Hypertension(3-02 Study)-

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

Omatsu Kazunori

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

senju-clinicaltrials@senju.co.jp

Clinical development division

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

+81-78-777-1018

senju-clinicaltrials@senju.co.jp

Recruiting

June. 28, 2024

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

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

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

Both

Primary open angle glaucoma or Ocular hypertension

Ocular administration of SJP-0170 or control drug

Change in intraocular pressure from baseline

Efficacy and Safety

+81-3-6779-8166

April. 26, 2024

No

none