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NOT YET RECRUITING
NCT07345416
NA

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.

View on ClinicalTrials.gov

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

DEVICE

ST-1

ST-1 lens worn in daily wear, daily disposable mode.

DEVICE

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