Unique ID issued by UMIN | UMIN000036453 |
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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 |
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
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
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
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
Japan |
Myopia in school children
Ophthalmology |
Others
NO
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.
Safety,Efficacy
Exploratory
Explanatory
Phase I,II
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.
Changes in axial lengths and cycloplegic objective refractions (spherical equivalent) from screening up to 6 months for each visit.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Device,equipment |
For 6 months, wearing only eyeglasses that emit violet light
For 6 months, wearing only pseudo-placebo-eyeglasses that emit violet light
6 | years-old | <= |
12 | years-old | >= |
Male and Female
(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.
(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.
40
1st name | Kazuo |
Middle name | |
Last name | Tsubota |
Tsubota Laboratory, Inc.
President and CEO
160-0016
304 Toshin-ekimae Bldg., 34 Shinanomachi Shinuku-ku, Tokyo
03-6384-2866
tsubota@tsubota-lab.com
1st name | Shinichiro |
Middle name | |
Last name | Kondo |
Tsubota Laboratory, Inc.
Research & Development Division
160-0016
304 Toshin-ekimae Bldg., 34 Shinanomachi Shinuku-ku, Tokyo
03-6384-2866
kondo@tsubota-lab.com
Tsubota Laboratory, Inc.
Tsubota Laboratory, Inc.
Profit organization
Japan
IRB at Shintokai Yokohama Minoru Clinic
1-13-8 Bessho, Minami-ku, Yokohama, Kanagawa
042-648-5551
jn-nomoto@epsogo.co.jp
NO
医療法人健究社 スマイル眼科クリニック(神奈川県)
2019 | Year | 04 | Month | 11 | Day |
NA
Unpublished
NA
41
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.
2021 | Year | 08 | Month | 18 | Day |
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.
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.
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.
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
Completed
2019 | Year | 02 | Month | 12 | Day |
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 04 | Month | 11 | Day |
2020 | Year | 07 | Month | 07 | Day |
2020 | Year | 07 | Month | 07 | Day |
2020 | Year | 10 | Month | 09 | Day |
2020 | Year | 11 | Month | 26 | Day |
2019 | Year | 04 | Month | 09 | Day |
2021 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041512
Research Plan | |
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Registered date | File name |
2021/08/18 | 治験実施計画書 20191206_Ver5.0.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |