Multicenter, retrospective study to assess the safety and efficacy of combination therapy with combination ophthalmic solutions for glaucoma in patients with primary open-angle glaucoma or ocular hypertension

UMIN ID: UMIN000046707

Registered date:24/01/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: primary open-angle glaucoma ocular hypertension
• Date of first enrollment: 2021/12/06
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in intraocular pressure from the date of prescription change to week 12 after the prescription change
• Secondary Outcome: 1) Percent change in intraocular pressure from the date of prescription change to week 12 after the prescription change 2) Measurement of intraocular pressure at the date of prescription change and at week 12 after the prescription change

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who had been treated by combination therapy with prostaglandin ophthalmic solution and combination ophthalmic solution with carbonic anhydrase inhibitor and beta-blocker for less than 8 weeks before the prescription change. 2) Patients with ocular measurements of less than 15 mmHg on the day of prescription change3) Patients with a history of glaucoma surgery (including laser surgery and cryocoagulation) in the eye subject to efficacy evaluation. 4) Patients who used bimatoprost ophthalmic solution before the prescription change. 5) Patients who used other ophthalmic solutions for glaucoma concomitantly during the observation period after the prescription change. 6) Patients whose medication adherence of combination therapy with latanoprost/carteolol ophthalmic solution and brimonidine/brinzolamide ophthalmic solution in the eye subject to efficacy evaluation was deemed to be poor after the change of prescription according to the medical records 7) Patients who were treated by glaucoma surgery (including laser surgery and cryocoagulation) or any other procedural treatment in the eye subject to efficacy evaluation during the observation period after the prescription change. 8) Patients who used other ophthalmic solutions for glaucoma in combination with prostaglandin ophthalmic solution and carbonic anhydrase inhibitor/beta-blocker combination ophthalmic solution during the period before the prescription change. 9) Patients who are judged by the investigators to be inappropriate for this study based on medical records.

Related Information

• Primary Sponsor: Yotsuya Shirato Eye Clinic
• Secondary Sponsor: Eye Rose Clinic Miyata Eye Hospital
• Source(s) of Monetary Support: Otsuka Pharmaceutical Co., Ltd.