Primary open-angle glaucoma (broad definition) or ocular hypertension
Conditions
Interventions
One drop of SJP-0135 ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 52 weeks.
Sponsors
Senju Pharmaceutical co.,ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent obtained after adequate explanation on participating the study 2) Japanese male or female outpatient, 20 years of age or older 3) Patients with primary open-angle glaucoma (broad definition) or ocular hypertension in both eyes
Exclusion criteria
Exclusion criteria: 1) History of surgical intervention or laser treatment for glaucoma 2) History of intraocular surgery 3) Presence of any circulatory failure such as cerebrovascular disease, orthostatic hypotension, cardiovascular disease and not eligible in the opinion of the investigator or the sub-investigator 4) Presence or history of bronchial asthma, bronchospasm or serious chronic obstructive pulmonary disease 5) Presence or history of uncontrolled heart failure, sinus bradycardia, atrioventricular block (Grade II or III) or cardiogenic shock 6) Presence of right heart failure caused by pulmonary hypertension, congestive heart failure, diabetic ketoacidosis, metabolic acidosis or uncontrolled diabetes mellitus 7) Serious visual field defect 8) History of corneal transplantation or keratorefractive surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events, ophthalmologic examination, blood pressure, pulse rate, laboratory test Efficacy: Changes from the baseline in intraocular pressure (IOP) at each visit (Hour 2) | — |
Countries
Japan
Contacts
Public ContactTakuro Sekiya
Senju Pharmaceutical co.,ltd. Clinical Development
Outcome results
None listed