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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

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 - 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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000046707
Enrollment
45
Registered
2022-01-24
Start date
2021-12-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary open-angle glaucoma ocular hypertension

Interventions

None listed

Sponsors

Yotsuya Shirato Eye Clinic
Lead Sponsor
Eye Rose Clinic Miyata Eye Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male and female 2) Outpatient 3) Patients who are aged 20 years or older at the time of study initiation 4) Patients who changed their prescription from combination therapy with prostaglandin ophthalmic solution and combination ophthalmic solution with carbonic anhydrase inhibitor and beta-blocker to combination therapy with latanoprost/carteolol ophthalmic solution and brimonidine/brinzolamide ophthalmic solution in both eyes or one eye by September 30, 2021, and whose intraocular pressure was measured on the day of the prescription change and week 12 (+-4 weeks) after the prescription change.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Change in intraocular pressure from the date of prescription change to week 12 after the prescription change

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactRei Sakata

Yotsuya Shirato Eye Clinic Ophthalmology

reisakata-tky@umin.ac.jp03-3355-4281

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026