UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	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
Scientific Title	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
Scientific Title:Acronym	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
Region	Japan

Condition
Condition	primary open-angle glaucoma ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to assess the safety and efficacy of combination therapy with latanoprost/carteolol combination ophthalmic solution and brimonidine/brinzolamide combination ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in intraocular pressure from the date of prescription change to week 12 after the prescription change
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Aihara
Organization	Yotsuya Shirato Eye Clinic
Division name	Ophthalmology
Zip code	160-0004
Address	Yotsuya Mitsuke building 3F, 1-1-2, Yotsuya, Shinjyuku-ku, Tokyo
TEL	03-3355-4281
Email	aihara-tky@umin.net

Public contact
Name of contact person	1st name Rei Middle name Last name Sakata
Organization	Yotsuya Shirato Eye Clinic
Division name	Ophthalmology
Zip code	160-0004
Address	Yotsuya Mitsuke building 3F, 1-1-2, Yotsuya, Shinjyuku-ku, Tokyo
TEL	03-3355-4281
Homepage URL
Email	reisakata-tky@umin.ac.jp

Sponsor
Institute	Yotsuya Shirato Eye Clinic
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Eye Rose Clinic Miyata Eye Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Miyata Eye Hospital IRB
Address	6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan
Tel	0986-22-1441
Email	ushihama@miyata-med.ne.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	45
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 10 Month 25 Day
Date of IRB	2021 Year 11 Month 02 Day
Anticipated trial start date	2021 Year 12 Month 06 Day
Last follow-up date	2021 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study will estimate the change in intraocular pressure from the date of prescription change to week 12 after the prescription change as efficacy endpoint and occurrence of side effect as safety endpoint in 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.

Management information
Registered date	2022 Year 01 Month 24 Day
Last modified on	2022 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053284