UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of contact lens wettability while wearing soft contact lens
Title of the study (Brief title)	Evaluation of 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	Purpose of this study is to evaluate and compare contact lens wettability among three kinds of soft contact lens 8 hour after wearing soft contact lens.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation contact lens wettability 8 hour after wearing soft contact lens.
Key secondary outcomes

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Silicone Hydrogel Contact Lens
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 who BUT is 5 or more than 5 seconds and do not have dry eye 3)Patients who wear soft spherical contact lenses (not for perspective or astigmatism) 4)Spherical power is -5.75 D and less than -5.75D 5)Women aged 20 years and under 45 years of age at the time of consent acquisition 6)A patient who understands the contents of the consent document and is able to consent in the document of the person 7)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	Bausch Lomb Japan
Organization
Division
Category of Funding Organization	Profit organization
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 05 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 28 Day
Anticipated trial start date	2018 Year 05 Month 08 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

Management information
Registered date	2018 Year 05 Month 07 Day
Last modified on	2018 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037068