An open-label, single-arm, multicenter study to evaluate the safety and efficacy of TLG-001J in elementary and junior high school students with myopia (TLG-001J LT Study) (TLG-001J LT Study)
TLG-001J LT Study (TLG-001J LT Study)
Mori Kiwako
Kojimachi Ave. Ophthalmology
3-2-5 Kojimachi, Chiyoda-ku, Tokyo
+81-3-6256-8588
morikiwako@gmail.com
Mori Kiwako
Kojimachi Ave. Ophthalmology
3-2-5 Kojimachi, Chiyoda-ku, Tokyo
+81-3-6256-8588
morikiwako@gmail.com
Not Recruiting
Feb. 28, 2024
Mar. 28, 2024
15
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
prevention purpose
1) Japanese male and female elementary and junior high school students with myopia aged 6~15 years at the time of obtaining consent
2) Patients with anisometropia within 1.50D
3) Patients with astigmatism within +/-1.50D in both eyes
4) Patients with corrected visual acuity of 1.2 or more in both eyes
5) Patients who can perform the procedure under control paralysis
6) Patients who can undergo a clinical examination according to the study protocol
7) Patients who have given written consent to participate in the study by themselves and their substitute consents
1) Patients with a history of ophthalmic surgery, including refractive surgery
2) Patients taking methoxalen (Oxolaren Tablets 10 mg)
3) Patients with a history or suspicion of photosensitivity
4) Patients with a history of epilepsy
5) Patients with binocular visual dysfunction
6) Patients with amblyopia or overt strabismus
7) Patients with a difference in objective refraction (SE) of 1.50D or more in each eye under accommodative and nonaccommodative paralysis
8) Patients with guttate cornea or corneal endothelial cell density less than 2,000 cells/mm^2
9) Patients with eye-related or systemic diseases that may affect visual acuity or refractive index other than myopia
10) Patients who take or have taken drugs that affect neurotransmitters or growth
11)Patients who have taken or will take supplements containing crocetin (However, if more than one month has passed since the end of intake of supplements containing crocetin, the product may be included.)
12) Patients who have received or have received atropine treatment, orthokeratology, multifocal (Includes progressive, double focus) glasses or contact lenses.
13) Patients with a history of allergy to fluorescein, oxybuprocaine hydrochloride (such as benoxilophthalmic solution 0.4%), cyclopentolate hydrochloride (cypledin 1% ophthalmic solution), or benzalkonium
14) Patients likely to require contact lenses (Monofocal, multifocal, orthokeratology, etc.) or multifocal glasses during the study period
15) Patients unable to wear study equipment continuously during the study period, including during extended vacation periods such as summer vacation
16) Patients who have used TLG-001 during exploratory and confirmatory clinical trials
17) Other patients who were deemed unsuitable for inclusion in this study by the responsible (shared) physician
6age old over
15age old under
Both
Myopia
During the study, the subjects wore the test equipment daily and received violet light irradiation for 3 hours per day.
Evaluation of adverse events up to 24 months in patients who discontinued treatment due to safety after starting use of TLG-001J
[Safety Evaluation]
1) Changes in the following safety endpoints from the time of screening (baseline) 24 months (96 weeks) after the start of use of the study equipment
(a) Visual acuity test using a Landolt ring (Uncorrected visual acuity)
(b) Morphological, structural, and quantitative evaluation of the retina using OCT (Retinal disease, macular disease, retinal thickness, choroidal thickness)
(c) Corneal endothelial cell density measurement using a corneal endothelial cell counter (corneal endothelial cell density)
(d) Observation of anterior segment and intermediate translucent body by slit-lamp (Corneal edema, anterior chamber inflammation, keratoconjunctival epithelial disorder, etc.)
(d) Monocular or binocular indirect ophthalmoscopy (fundus observation)
(d) Research responsibility (division) Skin disorder around the eyes due to the physician's opinion (Grade, site of onset)
2) For the study subjects who wore the study device continuously after 24 months (96 weeks), the changes from the time of screening (baseline) in the above safety endpoints for up to 36 months (144 weeks), etc.
[Evaluation of efficacy]
1) Changes in the following efficacy endpoints from the time of screening (baseline)
(a) Changes from baseline in axial length at 1 month (Week 4), 3 months (Week 12), 6 months (Week 24), 12 months (Week 48), 18 months (Week 72), and 24 months (Week 96) after the start of use of study equipment
(b) Changes from baseline in choroidal thickness at 12 months (Week 48) and 24 months (Week 96) after the start of use of study equipment
(c) Changes from baseline in the following indices at 1 month (Week 4), 12 months (Week 48), and 24 months (Week 96) after the start of use of study equipment
(i) Objective refraction under control paralysis: Spherical power (S)
(ii) Adjustable palsy-objective refractive value: cylinder power (C)
(iii) Adjustable palsy-objective refractive value: spherical equivalent (SE)
(iv) Adjustable palsy-subjective refractive value: spherical equivalent (S)
(v) Adjustable palsy-subjective refractive value: cylindrical equivalent (C)
(vi) Adjustable palsy-subjective refractive value: spherical equivalent (SE)
2) For study subjects who wore the study device continuously after 24 months (96 weeks), the change from screening (baseline) in the above efficacy endpoints for up to 36 months (144 weeks), etc.
