UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method
Acronym	Molded-RGP
Scientific Title	Evaluation of hard contact lenses with periodic exchange type oxygen permeability by molding method
Scientific Title:Acronym	Molded-RGP
Region	Japan

Condition
Condition	Patients using conventional oxygen-permeable hard contact lenses for more than five days a week
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The three-month regular exchange type oxygen-permeable hard contact lens by the mold process, while performing a regular exchange for one year, subjective symptoms, anterior eye findings, other haptic inspection, lens fitting, etc., The purpose of this study is to compare conventional oxygen-permeable hard-to-use lenses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparative evaluation of test items for three-month regular-exchange oxygen-permeable hard contact lenses by conventional oxygen-permeable hard contact lenses and moldprocess
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Three-month periodic exchange of oxygen-permeable hard contact lens by molding method
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients using conventional oxygen-permeable hard contact lenses for more than five days a week 2)Patients who came to the hospital in a state of conventional oxygen-permeable hard contact lenses with over six months of use during the first inspection. 3)Conventional oxygen-permeable hard contact lenses are spherical lenses (not for perspective or astigmatism) 4)Patients who wear conventional oxygen-permeable hard contact lenses throughout the day (patients who are not in continuous wear) 5)Patients aged 20 years and under 60 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 8)Men and women do not matter.
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)A patient who is a research director or researcher who is deemed unfit for the incorporate of this research 3)Patients judged by other research managers or researchers as inappropriate to implement this research safely
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Suzuki
Organization	Ishizuchi Eye Clnic
Division name	Director
Zip code	7920081
Address	1-8-30 Shonaicyo Niihama-city Ehime
TEL	0898-33-3069
Email	t-suzuki@ishizuchi-eye-clinic.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Suzuki
Organization	Ishizuchi Eye Clnic
Division name	Director
Zip code	7920811
Address	1-8-30 Shonaicyo Niihama-city Ehime
TEL	0898-33-3069
Homepage URL
Email	t-suzuki@ishizuchi-eye-clinic.jp

Sponsor
Institute	Ishizuchi Eye Clnic
Institute
Department

Funding Source
Organization	Menicon
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Riverside IRB
Address	Minamisitijounishi2-1 Chuoku Sapporro
Tel	0115212321
Email	rinrishinsa@riversideclinic.or.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	2018 Year 04 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	93
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	2018 Year 02 Month 17 Day
Date of IRB	2018 Year 02 Month 27 Day
Anticipated trial start date	2018 Year 04 Month 16 Day
Last follow-up date	2021 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 16 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036793