UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027047 |
|---|---|
| Receipt number | R000031002 |
| Scientific Title | Ocular circulation changes and intraocular pressure reduction induced by ripasudil or dorzolamido/timolol fixed combination added to prostaglandin agalogues in primary open angle glaucoma |
| Date of disclosure of the study information | 2017/05/09 |
| Last modified on | 2021/04/21 09:17:38 |
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Basic information
Public title
Ocular circulation changes and intraocular pressure reduction induced by ripasudil or dorzolamido/timolol fixed combination added to prostaglandin agalogues in primary open angle glaucoma
Acronym
Ocular circulation changes and intraocular pressure reduction induced by ripasudil or dorzolamido/timolol fixed combination added to prostaglandin agalogues in primary open angle glaucoma
Scientific Title
Ocular circulation changes and intraocular pressure reduction induced by ripasudil or dorzolamido/timolol fixed combination added to prostaglandin agalogues in primary open angle glaucoma
Scientific Title:Acronym
Ocular circulation changes and intraocular pressure reduction induced by ripasudil or dorzolamido/timolol fixed combination added to prostaglandin agalogues in primary open angle glaucoma
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of topical ripasudil or
COSOPT Ophtalmic Solution added to prostaglandin analogue on blood flow and vessel density optic nerve head and macula and intraocular pressure reduction in a randmized crossover study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of mean blur rate measured by laser
speckle flowgraphy and vessel density measured by OCT angio graphy in optic nerve head and macula after adding each topical.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adding topical ripasudil or cosopt ophtalmic solution to prostaglandin analogue.
Interventions/Control_2
Using each eye drop for 2 months
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who met all of the following inclusion criteria are included:best-corrected visual acuity of at least 15/25,spherical refractie errors between -6.00 and +6.00 diopters,and arefractive cylindrical error within +/-2.00D
Key exclusion criteria
Subjects who aren't satisfied with inclusion criteria.Subjects who have a history of intraocular surgery except for cataract.
Subjects who have a clinically significant retina-choroidal disease,vitreous disease,or corneal disease.Subjects who have high systolic blood pressure over 150mmHg or high diastolic pressure over 90mmHg at rest.Subjects who are taking Ca blocker,or alpha-1 blocker,or beta-1 blocker,or Sildenafil.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoko Ishida |
Organization
Department of Ophthalmology, Toho University Ohashi Medical Center.
Division name
Department of Ophthalmology
Zip code
Address
Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
kyoko.ish@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Ishida |
Organization
Department of Ophthalmology, Toho University Ohashi Medical Center.
Division name
Department of Ophthalmology
Zip code
Address
Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
kyoko.ish@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Toho University Ohashi Medical Center.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 09 | 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
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
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 18 | Day |
Last modified on
| 2021 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031002
