臨床研究等提出・公開システム

A double-masked, multicenter, randomized, controlled trial of a daily disposable contact lens for myopia control (MIST) for myopia in Japanese children

A double-masked, multicenter, randomized, controlled trial of a daily disposable contact lens for myopia control (MIST) for myopia in Japanese children

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The mean age was 10.3+-1.3 years in the Test group and 10.5+-1.3 years in the Control group and gender was 15 males (50.0%) in the Test group and 16 males (53.3%) in the Control group.

Informed consent ogtained: 66 subjects 112 eyes Aligible: 31 subjects 62 eyes in the Test group and 31 subjects 62 eyes in the Control group Dispensed lenses: 30 subjects 60 eyes in the Test group and 30 subjects 60 eyes in the Control group Completed 12-month: 29 subjects 58 eyes in the Test group and 30 subjects 60 eyes in the Control group Completed 24-month: 29 subjects 58 eyes in the Test group and 29 subjects 58 eyes in the Control group

There were 140 adverse events in 29 of 30 subjects (96.7%) in the Test group and 164 events in 30 of 30 subjects (100.0%) in the Control group and all events were non-serious event. 23 events in 12 subjects (40.0%) in the Test group and 14 events in 9 subjects (30.0%) in the Control group were ocular adverse events. All ocular adverse events were 'non-significant' and there was none of the ocular events were 'serious' or 'significant'.

Primary endpoint: Change in cycloplegic Spherical Equavalent Refractive Error (SERE) at 12-month visit was compared statistically using a linear mixed model. The estimated mean progression was -0.3721D for the Test group and -0.7939D in the Control group and the Test group exhibited less progression in cycloplegic SERE. The difference in progression SERE was 0.4217D less with the Test group and this differecne was statistically significant (p<0.0001). A clinically significant difference was concluded as the difference between groups was more than 0.25D at 12 month. Change in cycloplegic SERE at 12-month visit was compared statistically using MMRM. The difference in the estimated mean progression was 0.4164D (p<0.0001) and 0.6167D (p<0.0001) at the 12- and 24-month visits respectively and

The target study population was myopic Japanese children aged 8 to 12 years at Screening visit. The study was to quantify the effectiveness and safety of the Test lenses in slowing the rate of progression of juvenile-onset myopia compared to a conventional Control lenses and the Test group showed clinically effectiveness and safety for use in children.

Nov. 05, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2052210116

Misumi Nobuko

CooperVision Japan, Inc.

ARK Hills South Tower, 1-4-5 Roppongi, Minato-ku, Tokyo, JAPAN

nobuko.misumi@jp.coopervision.com

Misumi Nobuko

CooperVision Japan, Inc.

ARK Hills South Tower, 1-4-5 Roppongi, Minato-ku, Tokyo, JAPAN

+81-3-6779-4995

nobuko.misumii@jp.coopervision.com

Complete

Nov. 08, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

1. Subject who have read the informed assent form (IAF) for participation in the study, received an explanation of the IAF, understood the IAF, and can voluntarily consent to participate in the study.
2. The subject's legally acceptable representative has read the informed consent form (ICF), received and explanation of the ICF, understood the ICF, and can sign the ICF.
3. Subjects who understand the nature of the study and are willing to comply with the requirements, along with their legally acceptable representative.
4. Subjects who are willing to cooperate voluntarily with the study plan, such as following the follow-up schedule, along with their legally acceptable representative.
5. Subjects who can agree to be randomized.
6. Subjects who are willing to wear the study lens for 10 hours a day for at least 6 days a week during the study period. In addition, those who can agree to inform the investigator if this wearing schedule is suspended.
7. Subjects who have glasses with good vision available for use or will have glasses when they start to wear the study lenses.
8. Subjects who are generally in good health based on his/her and legally acceptable representative's knowledge.
9. Subjects who have a best-corrected visual acuity (BCVA) of +0.10 logMAR or more in each eye.
10. Subjects whose spherical equivalent power is -0.75 to -4.00D and cylindrical diopter is -0.75D or less and the difference in refractive power between right and left eyes is less than 1.00D in the cycloplegic refraction test using an autorefractometer at the initial visit.

1. Subjects who appears to have poor hygiene habits.
2. Subjects who are participating or have participated in another clinical study (clinical trial) within 30 days prior to this study.
3. The subject's legally acceptable representative is an employee including investigator at the medical institution of this study.
4. Subjects who have previously worn HCL (RGP lenses), including orthokeratology lenses.
5. Subjects who are currently receiving or have previously received any myopia control treatment such as bifocal/progressive contact lenses or atropine.
6. Subjects who regularly use ocular medications, including artificial tears (prescription or over-the-counter drugs).
7. Subjects with a history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, infectious ocular inflammation, or other recurrent ocular inflammation.
8. Subjects diagnosed with strabismus.
9. Subjects with known ocular or systemic disease, such as, but not limited to, anterior uveitis, iritis, episcleritis, scleritis, glaucoma, Sjogren's syndrome, systemic lupus erythematosus, scleroderma or diabetes mellitus.
10. Subjects with keratoconus or an irregular cornea.
11. An investigator considers that it is not in the best interest of the subject to participate in the study.

Both

Myopia and Myopic astigmatism

Enrolled subjects will be randomly assigned to either the test lens group or the control lens group, and either of daily disposal lenses will be prescribed according to the assignment results. Subjects will wear study lenses for 24 months.

Objective refractive power (spherical equivalent) under cycloplegic conditions

Axial length

+81-6-6395-9000

Sept. 10, 2021

none