JPRN-UMIN000026472Completed未知
A phase III comparative study to evaluate the efficacy and safety of SJP-0135 versus timolol in patients with primary open-angle glaucoma or ocular hypertension - A comparative study to evaluate the efficacy and safety of SJP-0135 versus timolol in patients with primary open-angle glaucoma or ocular hypertension
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 408
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
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
Investigators
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