UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the efficacy between two pattern multicurve RGPCL designs for modereate keratoconus
Title of the study (Brief title)	Comparison of the efficacy between two pattern multicurve RGPCL designs for modereate keratoconus
Region	Japan

Condition
Condition	keratoconus
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the design of multiplecurve RGPCL(rigd gas permerable contact lens)for moderate keratoconus, we compare the result between two pattern RGPCLs in the same eye
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Visual acuity of RGPCL after 2 weeek wearing Contrast visual acuity Wavefront aberration Questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	two week wearing of multiple curve RGPCL(M curve type)
Interventions/Control_2	two week wearing of multiple curve RGPCL (Twinbel bebel toric type)
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	the patients with moderate keratoconus who want to buy RGPCL
Key exclusion criteria	The pregnant patients The patients who have pain or some trouble with wearing RGPCL
Target sample size	10

Research contact person
Name of lead principal investigator	Chie Sotozono
Organization	Kyoto prefectural University of Medicine
Division name	Department of ophthalmology
Address	465Kajiicho,Kamigyo-ku,Kyoto-City, Kyoto
TEL	075-251-5578
Email	csotozon@koto.kpu-m.ac.jp

Public contact
Name of contact person	Keiko Yamagishi
Organization	Kyoto prefectual University of Medicine
Division name	Department of ophthalmology
Address	465Kajiicho,Kamigyo-ku,Kyoto-City, Kyoto
TEL	075-251-5578
Homepage URL
Email	khino@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Co. Sun contact lens
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	2016 Year 08 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 08 Month 24 Day
Anticipated trial start date	2016 Year 09 Month 01 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	2016 Year 08 Month 30 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027454