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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.
Summary
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).
Official title: A Randomized, Single-Masked, Active-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of ST-1 Silicone Hydrogel Daily Disposable Soft Contact Lenses Compared to Miru 1day UpSide
Key Details
Gender
All
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2026-05-01
Completion Date
2026-12-31
Last Updated
2026-01-15
Healthy Volunteers
Yes
Interventions
ST-1
ST-1 lens worn in daily wear, daily disposable mode.
Miru 1day UpSide
Miru 1day UpSide lens worn in daily wear, daily disposable mode.
Locations (6)
Changhua Christian Hospital
Changhua, Changhua City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, New Taipei City, Taiwan
Taipei Veterans General Hospital
Taipei, Taipei City, Taiwan
Tri-Service General Hospital
Taipei, Taipei City, Taiwan
Chang-Gung Memorial Hospital LinKou Branch
Taoyuan District, Taoyuan City, Taiwan