UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046707 |
|---|---|
| Receipt number | R000053284 |
| 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 |
| Date of disclosure of the study information | 2022/01/24 |
| Last modified on | 2022/10/21 10:36:14 |
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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
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
reisakata-tky@umin.ac.jp
Sponsor or person
Institute
Yotsuya Shirato Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053284
