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Phase IIb study of SNJ-1656; A dose-response study in patients with primary open angle glaucoma or ocular hypertension

Phase IIb study of SNJ-1656; A dose-response study in patients with primary open angle glaucoma or ocular hypertension - A dose-response study of SNJ-1656 in patients with primary open angle glaucoma or ocular hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018866
Enrollment
180
Registered
2015-08-31
Start date
2009-07-01
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 (POAG) or Ocular hypertension (OH)

Interventions

0.003% SNJ-1656 instilled in both eyes, b.i.d. for 4 weeks. 0.01% SNJ-1656 instilled in both eyes, b.i.d. for 4 weeks. 0.03% SNJ-1656 instilled in both eyes, b.i.d. for 4 weeks. Vehicle instilled in b

Sponsors

Senju Pharmaceutical co.,ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients had POAG or OH 2)IOP (hour 0) POAG:IOP of >=18.0 mmHg and <= 31.0 mmHg OH:IOP of >= 22.0 mmHg and <= 31.0 mmHg 3)Best corrected visual acuity of 0.5 or better 4)Patients who are completed designated washout at confirmation date of IOP 5)Change from baseline IOP (hour 0) at confirmation date of IOP <= 3.0 mmHg

Exclusion criteria

Exclusion criteria: 1)Active retinal disease 2)History of keratorefractive surgery or filtering surgery 3)History of trabeculotomy or laser trabeculoplasty in the study eye 4)Highly visual field loss 5)Corneal abnormalities that would preclude accurate readings with an applanation tonometer 6)Ocular surgery within 90 days 7)Use of contact lenses 8)Any active ocular disease other than glaucoma or OH 9)Uncontrolled systemic disease (eg, hepatic, renal, cardiovascular or endocrine system disease) 10)Women who were pregnant, nursing or who were of childbearing potential, or planning a pregnancy

Design outcomes

Primary

MeasureTime frame
Mean change from baseline intraocular pressure (IOP) at week 4 (Hour 0 and 2)

Countries

Japan

Contacts

Public ContactYoko Minagawa

Senju Pharmaceutical co.,ltd. Clinical Development

yoko_minagawa@senju.co.jp06-6201-9605

Outcome results

None listed

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