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Phase II study of SNJ-2022; An exploration study in patients with primary open angle glaucoma or ocular hypertension

Phase II study of SNJ-2022; An exploration study in patients with primary open angle glaucoma or ocular hypertension - An exploration study of SNJ-2022 in patients with primary open angle glaucoma or ocular hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019142
Enrollment
120
Registered
2015-09-28
Start date
2006-03-01
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

0.1% SNJ-2022 instilled in both eyes, b.i.d. for 4 weeks. 0.15% SNJ-2022 instilled in both eyes, b.i.d. for 4 weeks. Vehicle instilled in both eyes, b.i.d. for 4 weeks.

Sponsors

Senju Pharmaceutical co.,ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients had POAG or OH 2)Patients who needs the treatment with eye drops in both eyes 3)Patients were likely to be controlled on glaucoma medication 4)IOP (hour 0) POAG:IOP of >=18.0 mmHg and <= 31.0 mmHg OH:IOP of >= 22.0 mmHg and <= 31.0 mmHg 5)Best corrected visual acuity of 0.7 or better

Exclusion criteria

Exclusion criteria: 1)Any active ocular disease other than glaucoma or OH 2)Active retinal disease 3)History of keratorefractive surgery, filtering surgery, trabeculotomy in the study eye 4)Ocular surgery within 3 months in the study eye 5)Use of contact lenses 6)Allergy or serious side effect to alpha2-adrenergic agonist 7)Use of alpha-adrenoceptor agonist, alpha-adrenoceptor antagonist, beta-adrenergic agonist, beta-adrenoceptor antagonist, MAO inhibitor, adrenergic-augmenting psychotropic drugs, Central Nervous System Depressant 8)Patient with Impaired liver function, kidney disorder, depression, raynaud disease, thromboangiitis obliterans, orthostatic hypotension, cerebrovascular occlusion, coronary vessel occlusion, compromised circulation of serious cardiovascular disease 9)Women who were pregnant, nursing or who were of childbearing potential, or planning a pregnancy 10)Highly visual field loss 11)Corneal abnormalities that would preclude accurate readings with an applanation tonometer

Design outcomes

Primary

MeasureTime frame
Mean change from baseline intraocular pressure (IOP) at last visit (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