Primary open-angle glaucoma (broad definition) or ocular hypertension
Conditions
Interventions
One drop of 0.5% timolol 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-0135 is instilled into each eye twice-dail
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 4) Required ophthalmic solution for IOP-lowering treatment in both eyes 5) IOP =< 31.0 mmHg in each eye 6) Best corrected visual acuity >= 0.3 in each eye
Exclusion criteria
Exclusion criteria: 1) Prior ocular instillation of SJP-0135 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) Presence of any active retinal disease which may progress during the study 7) Presence of any active ocular disease other than primary open-angle glaucoma (broad definition) or ocular hypertension 8) Presence of a cancer or a serious systemic disease 9) Presence of any circulatory failure such as cerebrovascular disease, orthostatic hypotension, cardiovascular disease 10) Presence or history of bronchial asthma, bronchospasm or serious chronic obstructive pulmonary disease 11) Presence or history of uncontrolled heart failure, sinus bradycardia, atrioventricular block (Grade II or III) or cardiogenic shock 12) Presence of right heart failure caused by pulmonary hypertension, congestive heart failure, diabetic ketoacidosis, metabolic acidosis or uncontrolled diabetes mellitus 13) 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 the study drug or other alpha-2 receptors agonist or other beta-adrenergic receptor antagonist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in IOP (hour 2) from baseline at Week 4. | — |
Countries
Japan
Contacts
Public ContactTakuro Sekiya
Senju Pharmaceutical co.,ltd. Clinical Development
Outcome results
None listed