UMIN-CTR Clinical Trial

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

Patients with ocular sequelae due to Stevens-Johnson syndrome(SJS)

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Kyoto university hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2014

Year

06

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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