An open-label randomized controlled trial of MCS-612 in Japanese myopic children

JRCT ID: jRCT2052230056

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild and moderate myopia and myopic astigmatism
• Date of first enrollment: 24/06/2023
• Target sample size: 111
• Study type: Interventional
• Intervention(s): Subjects are randomized to wear contact lenses for 2 years.

Outcome(s)

• Primary Outcome: Change of the axial length at week 104th

Secondary Outcome

Change of the axial length at week 52th
Improvement in unaided visual acuity

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 12age old
• Gender: Both

Include criteria

1) Children aged 6 to 12 at the time of consent acquisition.
2) Children whose cycloplegic objective spherical power of both eyes is from -1.00 to -4.00D.
3) Children whose cycloplegic astigmatism is not higher than half of the spherical power. However, in case of against-the-rule astigmatism, not higher than half of the spherical power and not higher than 0.75D.
4) Children whose corneal refractive power is from 39.00D to 47.00D in both eyes.
5) Children whose Schirmer I test result is not less than 5mm in 5 minutes.
6) Children whose corneal endothelial cell density is 2000 cells/mm2 or more
7) Children whose cycloplegic difference in spherical equivalent between left and right eyes is within 1.50D
8) Children with best corrected visual acuity of 1.0 or more in both eyes
9) Children who can undergo cycloplegia

Exclude criteria

1) Children with disorder of visual function
2) Children with manifest strabismus
3) Children with corneal and conjunctiva findings (equal or more than those marked with * in the slit lamp microscopy evaluation criteria table)
4) Children with ocular or systemic disease that can affect vision and refractive power
(5) Children who is wearing or have worn RGP lenses including Orthokeratology
(6) Children who are receiving or have received myopia treatment with bifocal or multifocal spectacles or contact lenses, or medicines, supplements containing crocetin, etc.
(7) Children who are judged to be inappropriate for wearing the investigational device
(8) Children wearing contact lens monocularly
(9) Children who is participating in or have participated in other clinical trials, in any area within the last 3 months, or who is planning to participate in a clinical trial within this trial period.

Related Information

• Primary Sponsor: Nakamura Kikue