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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027047
Receipt No. 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 2017/04/18

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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
Email 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
Email kyoko.ish@gmail.com

Sponsor
Institute Department of Ophthalmology, Toho University Ohashi Medical Center.
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 09 Day
Last follow-up date
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
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031002

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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