UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of contact lens care on contact lens wettability while wearing soft contact lens
Title of the study (Brief title)	Effect of contact lens care on contact lens wettability
Region	Japan

Condition
Condition	Patients using soft contact lenses for more than five days a week
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to compare water wettability on the soft contact lens using two kinds of soft contact lens care products.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparative evaluation of ophthalmic examinations after using two types of soft contact lens care products
Key secondary outcomes

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	45 years-old >=
Gender	Female
Key inclusion criteria	1)Patients using soft contact lenses for more than five days a week 2)Patients dryness score of CLDEQ-8 is greater than or equal to 4 points 3)Patients who BUT is 5 or more than 5 seconds and do not have dry eye 4)Patients who wear soft spherical contact lenses (not for perspective or astigmatism) 5)Spherical power is -5.75 D and less than -5.75D 6)Women aged 20 years and under 45 years of age at the time of consent acquisition 7)A patient who understands the contents of the consent document and is able to consent in the document of the person 8)Patient who can come to the observation day by the instruction of the researcher
Key exclusion criteria	1)Patients who may affect the orthodontic vision of contact lenses due to diseases such as keratoconus, ptosis, and dry eye 2)Patients who have allergy and infectious ocular conditions. 3)A patient who is a research director or researcher who is deemed unfit for the incorporate of this research 4)Patients judged by other research managers or researchers as inappropriate to implement this research safely
Target sample size	10

Research contact person
Name of lead principal investigator	Takashi Suzuki
Organization	Ishizuchi Eye Clinic
Division name	Director
Address	1-8-30 Shonaicho Niihama-city Ehime
TEL	0897-33-3069
Email	t-suzuki@ishizuchi-eye-clinic.jp

Public contact
Name of contact person	Takashi Suzuki
Organization	Ishizuchi Eye Clinic
Division name	Director
Address	1-8-30 Shonaicho Niihama-city Ehime
TEL	0897-33-3069
Homepage URL
Email	t-suzuki@ishizuchi-eye-clinic.jp

Sponsor
Institute	Ishizuchi Eye Clinic
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2018 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 30 Day
Anticipated trial start date	2018 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2018 Year 11 Month 14 Day
Last modified on	2018 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039699

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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