A phase III comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertensio

Not Applicable

• Conditions: Primary open-angle glaucoma (broad definition) or ocular hypertension

• Registration Number: JPRN-UMIN000028494
• Lead Sponsor: Senju Pharmaceutical Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified