UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023831
Receipt number R000027454
Scientific Title Comparison of the efficacy between two pattern multicurve RGPCL designs for modereate keratoconus
Date of disclosure of the study information 2016/08/31
Last modified on 2018/09/04 09:21:20

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Basic information

Public title

Comparison of the efficacy between two pattern multicurve RGPCL designs for modereate keratoconus

Acronym

Comparison of the efficacy between two pattern multicurve RGPCL designs for modereate keratoconus

Scientific Title

Comparison of the efficacy between two pattern multicurve RGPCL designs for modereate keratoconus

Scientific Title:Acronym

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

1st name
Middle name
Last name Chie Sotozono

Organization

Kyoto prefectural University of Medicine

Division name

Department of ophthalmology

Zip code


Address

465Kajiicho,Kamigyo-ku,Kyoto-City, Kyoto

TEL

075-251-5578

Email

csotozon@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiko Yamagishi

Organization

Kyoto prefectual University of Medicine

Division name

Department of ophthalmology

Zip code


Address

465Kajiicho,Kamigyo-ku,Kyoto-City, Kyoto

TEL

075-251-5578

Homepage URL


Email

khino@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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)



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

2016 Year 08 Month 31 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

Terminated

Date of protocol fixation

2016 Year 08 Month 24 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027454


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name