UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014148 |
|---|---|
| Receipt number | 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 11:27:40 |
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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
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
csotozon@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016476
