UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031002