UMIN-CTR Clinical Trial

Basic information
Public title	Association between temperature and blood flow in dry eye patients
Acronym	Association between temperature and blood flow in dry eye patients
Scientific Title	Association between temperature and blood flow in dry eye patients
Scientific Title:Acronym	Association between temperature and blood flow in dry eye patients
Region	Japan

Condition
Condition	Dry eye patients
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure ocular surface temperature and ocular blood flow in patients with dry eye, and to clarify the relationship between ocular surface blood flow and temperature according to the clinical findings of dry eye and the severity of subjective symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ocular surface temperature Blood flow
Key secondary outcomes	subjective symptom tear film stability

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Dry eye patients aged 20 years and older
Key exclusion criteria	Patients with allergic conjunctivitis, corneal infection, and within one month after ophthalmic surgery
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hori Middle name Last name Yuichi
Organization	Toho University Omori medical center
Division name	Ophthalmology
Zip code	143-8541
Address	ota ku omori nish 6-11-1
TEL	0337624151
Email	takashi.itokawa@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Itokawa Middle name Last name Takashi
Organization	Toho university omori medical center
Division name	Ophthalmology
Zip code	143-8541
Address	Ota ku omori nish 6-11-1
TEL	0337624151
Homepage URL
Email	takashi.itokawa@med.toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical center
Institute
Department

Funding Source
Organization	Toho University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toho university omori medical center
Address	Ota ku Omori Nish 6-11-1
Tel	0337624151
Email	takashi.itokawa@med.toho-u.ac.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 08 Month 10 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 21 Day
Date of IRB	2021 Year 09 Month 03 Day
Anticipated trial start date	2021 Year 09 Month 07 Day
Last follow-up date	2024 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 08 Month 10 Day
Last modified on	2022 Year 08 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051840