Primary open-angle glaucoma (broad definition) or ocular hypertension
Conditions
Interventions
One drop of 0.1% brimonidine tartrate ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of SJP-0125 is instilled into each e
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 4) Required ophthalmic solution for IOP-lowering treatment 5) IOP =< 31.0 mmHg 6) Best corrected visual acuity >= 0.3
Exclusion criteria
Exclusion criteria: 1) Prior ocular instillation of SJP-0125 2) History of surgical intervention or laser treatment for glaucoma 3) History of intraocular surgery within past 90 days 4) Anticipated wearing of any contact lenses 5) Intraocular injection, sub-Tenon or subconjunctival injection of a corticosteroid agent within past 180 days 6) Patients who are pregnant, breastfeeding, or potentially pregnant. or who desire to be pregnant or who do not intend to prevent conception from consent to the end of the treatment period 7) Participated in any other clinical trial within past 90 days and received any other investigational drug or plans to participate in any other clinical trial during the study 8) Presence of any active retinal disease which may progress during the study 9) Presence of any active ocular disease other than primary open-angle glaucoma (broad definition) or ocular hypertension 10) Presence of a cancer or a serious systemic disease 11) Presence of any circulatory failure 12) Presence of corneal disorder 13) Presence of serious visual field defect 14) Presence of corneal abnormality which is considered to preclude accurate measurement of IOP by Goldmann applanation tonometer 15) History of corneal transplantation or keratorefractive surgery 16) History of allergy or significant adverse drug reaction to any ingredients of drugs used in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in IOP (hour 2) from the start day of the treatment period at Week 4. | — |
Countries
Japan
Contacts
Public ContactTakuro Sekiya
Senju Pharmaceutical Co.,Ltd. Clinical Development
Outcome results
None listed