UMIN-CTR Clinical Trial

Basic information
Public title	changes ocular surface temperature and tear film stability during instillation over soft contact lenses
Acronym	Changes ocular surface temperature and tear film stability over SCL
Scientific Title	changes ocular surface temperature and tear film stability during instillation over soft contact lenses
Scientific Title:Acronym	Changes ocular surface temperature and tear film stability over SCL
Region	Japan

Condition
Condition	soft contact lenses wearer
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Currently, it is said that there are 14 million contact lens wearers in our country. Wearing contact lenses is known as one of the causes of decreasing tears and inducing eye dryness (dry eye), and there are many wearers who are doing dry eye eye drops from above contact lenses. However, it is still unknown what the state of the ocular surface looks like when instilling eye drops on the contact lens. Therefore, in order to investigate the condition on the contact lens after instillation, we examined the contact lens wearer 's eye drop eye dry eye therapeutic agent "diquasofol sodium" from the contact lens on the eye surface temperature change and tears Examine the liquid dynamics.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate sustained effect of diquasofol sodium by ocular surface temperature change
Key secondary outcomes	Evaluate sustained effect of diquasofol sodium by non invasive tear break up time and tear menisucus change

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Drop a single drop of diquasofol sodium and evaluate before and after 5, 15, 30 ,60 minutes after instillation.
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	100 years-old >
Gender	Male
Key inclusion criteria	soft contact lenses wearer
Key exclusion criteria	ocular disease
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Itokawa
Organization	Toho university medical center
Division name	Ophthalmology
Zip code
Address	6-11-1 Omori Nishi Ota-ku, Tokyo
TEL	03-3761-4151
Email	takashi.itokawa@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Itokawa
Organization	Toho university medical center
Division name	Ophthalmology
Zip code
Address	6-11-1 Omori Nishi Ota-ku, Tokyo
TEL	03-3761-4151
Homepage URL
Email	takashi.itokawa@med.toho-u.ac.jp

Sponsor
Institute	Toho university medical center
Institute
Department

Funding Source
Organization	Toho university medical center
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
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 06 Month 06 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	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2016 Year 12 Month 12 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 06 Month 06 Day
Last modified on	2020 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031692