UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014148
Receipt No. R000016476
Scientific Title Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100 for ocular sequelae due to Stevens-Johnson syndrome
Date of disclosure of the study information 2014/06/03
Last modified on 2015/03/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100 for ocular sequelae due to Stevens-Johnson syndrome
Acronym Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100
Scientific Title Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100 for ocular sequelae due to Stevens-Johnson syndrome
Scientific Title:Acronym Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100
Region
Japan

Condition
Condition Patients with ocular sequelae due to Stevens-Johnson syndrome(SJS)
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this clinical trial is to evaluate the safety and therapeutic benefits of the limbal-supported CL CS-100 in patients with ocular sequelae caused by SJS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes The main outcome measure is over LogMAR 0.2 improvement rate of bestcorrected visual acuity(BCVA) at before CL fitting and at after 3 months use of the limbal-supported CL post fitting
Key secondary outcomes (1) Change value of bestcorrected visual acuity(BCVA) at before CL fitting and at after 3 months use of the limbal-supported CL post fitting
(2) Change value of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite score
(3) Change severity of pain and dryness in the eye (VAS scale)
(4) Incidence rates and severities of adverse events

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use of the limbal-supported CL
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
75 years-old >
Gender Male and Female
Key inclusion criteria (1) Being diagnosed with keratoconjunctival disease due to SJS
(2) BCVA is upper than or equal to 0.01 less than 0.7
(3) Less than 5mm with Schirmer's tear test I
(4) Being 20 years of age or older and
younger than 76 years of age at the time
of recruit
(5) Patients treated as an outpatient
(6) Patients from whom written informed consent is obtained
Key exclusion criteria (1) Patients who are beleived to be inappropriate due to complications below;
- An acute or sub-acute inflammation of anterior eye part
- An active corneal infection
- An uveitis
(2) Patients who are hypersensitive to fit CL
(3) Patients who are believed to be exposed to dust and chemical drug with eyes
(4) Patients who are believed to have trouble with fit CL
(5) Patients performed ocular operations (such as cataract surgery, surgery of glaucoma treatment, corneal transplantation and so on) within latest 3 months
(6) Patients for whom it has been determined by the medical doctors that there will be complicating issues with the patient participating in the clinical trial for other reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chie Sotozono, M.D., Ph.D.
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5577
Email csotozon@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Sotozono, M.D., Ph.D.
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5577
Homepage URL
Email csotozon@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 S-001
Org. issuing International ID_1 Kyoto Prefectural University of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW 26-12 / 2014-D1

Institutions
Institutions 京都府立医科大学附属病院(京都府)、京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 03 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 Completed
Date of protocol fixation
2014 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 04 Day
Last follow-up date
2014 Year 12 Month 17 Day
Date of closure to data entry
2014 Year 12 Month 26 Day
Date trial data considered complete
2015 Year 01 Month 16 Day
Date analysis concluded
2015 Year 02 Month 26 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 03 Day
Last modified on
2015 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016476

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.