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 |
Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100 for ocular sequelae due to Stevens-Johnson syndrome
Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100
Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100 for ocular sequelae due to Stevens-Johnson syndrome
Clinical trial of tear exchangeable limbal supported rigid contact lens CS-100
Japan |
Patients with ocular sequelae due to Stevens-Johnson syndrome(SJS)
Ophthalmology |
Others
NO
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
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
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
(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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Use of the limbal-supported CL
20 | years-old | <= |
75 | years-old | > |
Male and Female
(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
(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
10
1st name | |
Middle name | |
Last name | Chie Sotozono, M.D., Ph.D. |
Kyoto Prefectural University of Medicine
Department of Ophthalmology
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
075-251-5577
csotozon@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Chie Sotozono, M.D., Ph.D. |
Kyoto Prefectural University of Medicine
Department of Ophthalmology
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto, Japan
075-251-5577
csotozon@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Ministry of Health, Labour and Welfare
Kyoto university hospital
YES
S-001
Kyoto Prefectural University of Medicine
26-12 / 2014-D1
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)
2014 | Year | 06 | Month | 03 | Day |
Unpublished
Completed
2014 | Year | 04 | Month | 07 | Day |
2014 | Year | 06 | Month | 04 | Day |
2014 | Year | 12 | Month | 17 | Day |
2014 | Year | 12 | Month | 26 | Day |
2015 | Year | 01 | Month | 16 | Day |
2015 | Year | 02 | Month | 26 | Day |
2014 | Year | 06 | Month | 03 | Day |
2015 | Year | 03 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016476