A Clinical Trial Assessing the Efficacy and Safety of ST-1 Silicone Hydrogel Daily Disposable Soft Contact Lenses Compared to Miru 1day UpSide

Sponsor
Menicon Co., Ltd.
Study ID
NCT07345416
Status
Not Yet Recruiting

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Conditions

  • Daily Disposable Soft Contact Lenses
  • Myopia
  • Soft Contact Lenses

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • ST-1 — DEVICE
    ST-1 lens worn in daily wear, daily disposable mode.
  • Miru 1day UpSide — DEVICE
    Miru 1day UpSide lens worn in daily wear, daily disposable mode.

Study Details

This study will enroll 63 eligible subjects (126 eligible eyes, complete at least 108 evaluable eyes) in approximately 6 different medical centers in Taiwan, in order to evaluate the efficacy and safety of ST-1 silicone hydrogel daily disposable soft contact lenses (ST-1 lenses) compared to Miru 1day UpSide. Enrolled subjects will be randomized in a 2:1 test to control ratio at Visit 1. Each site will enroll 8 (intended minimum) to 12 (intended maximum) subjects. In order to eliminate the bias, the Investigators and the evaluators will be masked to the treatment assignment of the randomization code. During the study, the Investigator(s) will examine the ocular health via inquiry, slit lamp biomicroscopy (SLB), visual acuity (VA) test, keratometry, and refractive changes. The Investigator(s) will check ocular health and evaluate the inclusion/exclusion criteria of subjects at screening. After entering the study, subjects will be required to wear the lenses on a daily basis, record daily wearing time on a diary, return to the study site at scheduled visits for evaluations and complete the self-assessment questionnaire at Visit 2 to Visit 7 (1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months).

Key Dates

First listed
Jan 15, 2026
Start date
May 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ST-1
    Subjects will be randomized at Visit 1 with a 2:1 allocation ratio (approximately two-thirds assigned to this arm).
  • Active Comparator: Miru 1day UpSide
    Subjects will be randomized at Visit 1 with a 2:1 allocation ratio (approximately one-third assigned to this arm).

Primary Outcome Measure

Corrected distance Logarithm of the Minimum Angle of Resolution (logMAR) visual acuity at the final visit (Visit 7) [ Time Frame: Screening, 3 months following enrolment ]

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