UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036453
Receipt number R000041512
Scientific Title Exploratory Clinical Trial, Randomized, Double-Blind, Pseudo-Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of TLG-001 in Subjects with Myopic School Children
Date of disclosure of the study information 2019/04/11
Last modified on 2021/08/19 17:28:21

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Basic information

Public title

Exploratory Clinical Trial, Randomized, Double-Blind, Pseudo-Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of TLG-001 in Subjects with Myopic School Children

Acronym

Exploratory Clinical Trial, Randomized, Double-Blind, Pseudo-Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of TLG-001 in Subjects with Myopic School Children

Scientific Title

Exploratory Clinical Trial, Randomized, Double-Blind, Pseudo-Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of TLG-001 in Subjects with Myopic School Children

Scientific Title:Acronym

Exploratory Clinical Trial, Randomized, Double-Blind, Pseudo-Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of TLG-001 in Subjects with Myopic School Children

Region

Japan


Condition

Condition

Myopia in school children

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the safety and efficacy using eyeglasses that emit violet light for a suppressive effect on myopia progression in myopic school children (elementary school students from 1st to 6th grade) who are considered to progress myopia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Safety evaluation by comparison of results of visual acuity, intraocular pressure, eye position, tear break up time (BUT), and corneal endothelial cell density, etc from screening up to 6 months for each visit.

Key secondary outcomes

Changes in axial lengths and cycloplegic objective refractions (spherical equivalent) from screening up to 6 months for each visit.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

For 6 months, wearing only eyeglasses that emit violet light

Interventions/Control_2

For 6 months, wearing only pseudo-placebo-eyeglasses that emit violet light

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

6 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Male and female Japanese school children from 6 to 12 years of age (elementary school from 1st to 6th grade) at the time of obtaining informed consent.
(2) School children whose cycloplegic objective refraction (spherical equivalent) for each eye is between -1.50 D and -4.50 D.
(3) School children with anisometropia within 1.50 D.
(4) School children with astigmatism within plus/minus 1.50 D for each eye.
(5) School children with corrected visual acuity equal or exceeding 1.0 for each eye.
(6) School children who can use cycloplegia.
(7) School children who can attend the clinic for consultations in accordance with the protocol.
(8) School children and their legally acceptable representative who can provide written informed consent.
(9) School children with at least one parent who is myopia.

Key exclusion criteria

(1) School children who have received ophthalmic operation,
including refractive surgeries previously.
(2) School children who take psoralen.
(3) School children who have previous history of photosensitivity or its suspect.
(4) School children who have previous history of epilepsy.
(5) School children with binocular visual function impairment.
(6) School children with amblyopia or manifest strabismus.
(7) School children who have a 1.50D or larger difference between bilateral eyes in both cycloplegic and non-cycloplegic objective refractions (spherical equivalent).
(8) School children who have previous or current history of myopia treatment.
(9) School children who have previous history of allergy against test drugs that are used in this study.
(10) School children who cannot wear eyeglasses continuingly that are used in this study.
(11) School children whose family member (brother, sister or etc.) living together participates in this study.
(12) School children who are judged to be inappropriate as subjects for this study by the principle investigator (or investigators) for the study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name Tsubota

Organization

Tsubota Laboratory, Inc.

Division name

President and CEO

Zip code

160-0016

Address

304 Toshin-ekimae Bldg., 34 Shinanomachi Shinuku-ku, Tokyo

TEL

03-6384-2866

Email

tsubota@tsubota-lab.com


Public contact

Name of contact person

1st name Shinichiro
Middle name
Last name Kondo

Organization

Tsubota Laboratory, Inc.

Division name

Research & Development Division

Zip code

160-0016

Address

304 Toshin-ekimae Bldg., 34 Shinanomachi Shinuku-ku, Tokyo

TEL

03-6384-2866

Homepage URL


Email

kondo@tsubota-lab.com


Sponsor or person

Institute

Tsubota Laboratory, Inc.

Institute

Department

Personal name



Funding Source

Organization

Tsubota Laboratory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB at Shintokai Yokohama Minoru Clinic

Address

1-13-8 Bessho, Minami-ku, Yokohama, Kanagawa

Tel

042-648-5551

Email

jn-nomoto@epsogo.co.jp


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

医療法人健究社 スマイル眼科クリニック(神奈川県)


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 11 Day


Related information

URL releasing protocol

NA

Publication of results

Unpublished


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

41

Results

There was no safety issue of the investigational devices in 41 cases to be analyzed. In a subgroup analysis, the amount of change in axial length and the amount of change in objective and subjective refraction values under accommodative paralysis are all statistical. There was a significant difference in. In the primary safety endpoints such as visual acuity and intraocular pressure, no significant difference was observed between the test device group and the control device group at any time of visit.

Results date posted

2021 Year 08 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The average age in the investigational device group was 9.8 years and 9.6 years in the control device group, with a tendency for the 8-10 age bracket to be the largest in both groups but with no significant intergroup difference.

Participant flow

This trial will enroll 40 myopic schoolchildren aged 6-12 years of age. Subjects with eligibility confirmed through screening will be asked to make a clinical visit to receive the clinical trial device, and subsequent clinical visits at 1-, 3-, and 6-month points for various clinical tests. The clinical trial device will be retrieved from subjects or their legal guardians during a clinical visit 6 months following completion, or suspension, of the clinical trial.

Adverse events

During the clinical trial there were 12 reported cases of adverse events such as influenza, but none was a serious event. Among these cases, a causal relationship with the clinical trial device could not be ruled out for application site reactions (erythema), of which there was 1 case each in the investigational and control device groups. In each case, an adjustment of the device frame resulted in a disappearance of the skin irritation. As application site erythema depends on frame fitting and individual predisposition, irradiation was determined to have no impact.

Outcome measures

Safety evaluation
Determine if safety of investigational and control devices are found to be identical when compared during baseline and 6-month-point clinical visits
Determine if frequency of side effects and other issues related to the investigational and control devices are found to be identical during the usage period (from acquisition of assent through conclusion of the clinical trial)
Criteria
1.Visual acuity (corrected)
2.Intraocular pressure through noncontact tonometry
3.Ocular alignment
4.BUT evaluation through corneal fluorescein staining, subjective symptoms
5.Corneal endothelial cell density
6.Findings through slit lamp microscope, fundoscopy
7.Morphological/structural retinal evaluation using retinal optical coherence tomography (OCT)
8.Dermopathy (periocular skin)
9.Adverse events/issues

Evaluation of the clinical efficacy
Evaluation of axial length in the investigational device group during the clinical baseline visit and at the 6-month point
Evaluation of cycloplegic objective refraction value (spherical equivalent) during the clinical baseline visit and at the 6-month point
Criteria
1.Axial length measurement using an optical axial length measurement device
2.Measurement of cycloplegic objective refraction value (spherical equivalent) using an autorefractometer

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 02 Month 12 Day

Date of IRB

2019 Year 03 Month 14 Day

Anticipated trial start date

2019 Year 04 Month 11 Day

Last follow-up date

2020 Year 07 Month 07 Day

Date of closure to data entry

2020 Year 07 Month 07 Day

Date trial data considered complete

2020 Year 10 Month 09 Day

Date analysis concluded

2020 Year 11 Month 26 Day


Other

Other related information



Management information

Registered date

2019 Year 04 Month 09 Day

Last modified on

2021 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041512


Research Plan
Registered date File name
2021/08/18 治験実施計画書 20191206_Ver5.0.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name