Randomized double-blind controlled trial of soft contact lenses EDOF150 in Japanese children with myopia

JRCT ID: jRCT2032220242

Registered date:04/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Mild and moderate myopia and myopic astigmatism
• Date of first enrollment: 25/07/2022
• Target sample size: 160
• Study type: Interventional
• Intervention(s): Randomly assigned to test group or control group, subjects will wear either contact lenses lens according to the randomization for two years. After two years all subjects will wear control lenses for a year.

Outcome(s)

• Primary Outcome: Change of the cycloplegic refractive (spherical equivalent) and axial length at week 104th compared to pre-examination (baseline).
• Secondary Outcome: Change of the cycloplegic refractive (spherical equivalent) and axial length at week 26th, 52th and 78th compared to pre-examination (baseline).

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 with cycloplegic objective refractive error (spherical equivalent) in both eyes from -0.75 to -6.00D.
3) Children with cycloplegic astigmatism no more than 1.00D.
4) Children with cycloplegic spherical equivalent difference of 1.50D or less between the left and right eyes.
5) Children with best corrected visual acuity of 1.0 or higher in each eye.
6) Children who can undergo cycloplegia.
7) Children who can attend all scheduled visits according to the clinical trial plan.
8) Children who along with their legal guardians (parents) have been signed the informed consent form to participate in this clinical trial.

Exclude criteria

1) Children with visual function disorder
2) Children with amblyopia and or manifest strabismus
3) Children with corneal and conjunctiva findings
4) Children with ocular or systemic disease that can affect vision and refractive power
5) Children who are treated or have been treated for myopia with bifocal or multifocal contact lenses, orthokeratology, drugs, crocetin-containing supplements, etc.
6) Children who are judged to be inappropriate for wearing soft contact lenses
7) Children wearing or have experience wearing contact lenses
8) Children wearing contact lens monocularly
9) Children who participate in or have participated in other clinical trials, in any area within the last 3 months, or who plan to participate in a clinical trial within this trial period.
10) Childrenwho are judged to be unsuitable as subjects for this clinical trial by the principal investigator or other investigators.

Related Information

• Primary Sponsor: Nakamura Kikue