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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; Soft Contact Lenses; Daily Disposable Soft Contact Lenses
• Intervention / Treatment: Device: ST-1; Device: Miru 1day UpSide

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua City
    • Changhua, Changhua City, Taiwan, 50006
      • Changhua Christian Hospital
      • Contact: Jian-Sheng Wu; Phone Number: +886-4-723-8595; Email: 125181@cch.org.tw
      • Principal Investigator: Jian-Sheng Wu
  • Kaohsiung City
    • Kaohsiung City, Kaohsiung City, Taiwan, 80756
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Contact: Shiuh-Liang Hsu; Phone Number: +886-7-312-1101; Email: shiuhlianghsu@gmail.com
      • Principal Investigator: Shiuh-Liang Hsu
  • New Taipei City
    • New Taipei City, New Taipei City, Taiwan, 220
      • Far Eastern Memorial Hospital
      • Contact: Tzu-Yun Tsai; Phone Number: +886-2-8966-7000; Email: ceciliatsai1978@gmail.com
      • Principal Investigator: Tzu-Yun Tsai
  • Taipei City
    • Taipei, Taipei City, Taiwan, 11217
      • Taipei Veterans General Hospital
    • Taipei, Taipei City, Taiwan, 114202
      • Tri-Service General Hospital
      • Contact: Tzu-Heng Weng; Phone Number: +886-2-8792-3311; Email: Aheng7435@gmail.com
      • Principal Investigator: Tzu-Heng Weng
  • Taoyuan City
    • Taoyuan District, Taoyuan City, Taiwan, 33305
      • Chang-Gung Memorial Hospital LinKou Branch
      • Contact: Yu-Chuan Kang; Phone Number: +886-3-328-1200; Email: yckang0321@gmail.com
      • Principal Investigator: Yu-Chuan Kang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. With either gender aged between 18 to 40 (inclusive) years old.
2. Diagnosis of myopia in both eyes, each ranging from -0.50D to 6.00D with manifest astigmatism of ≤ 1.00D per eye.
3. Understands and signs an informed consent form (ICF).
4. Willing to adhere to the instructions set forth in this study as well as understand and complete all specified evaluation.
5. Willing and able to refrain from using any other contact lenses other than those provided for the duration of the study.
6. Has experience and capability of wearing soft contact lenses.
7. Be a habitual soft contact lenses wearer in both eyes, defined as wearing lenses for at least 8 hours per day, 5 days per week, for a minimum duration of 30 days.
8. Tear breakup time (TBUT) > 5 seconds in each eye.

Exclusion Criteria:

1. Eyes with abnormality or disease as follows:

   1. Evidence of lid abnormality or infection (e.g., entropion, ectropion, chalazia, and recurrent styes).
   2. Clinically significant slit lamp findings (e.g., infiltrates or other slit lamp findings Level 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
   3. Other active ocular disease (e.g., uveitis, corneal epithelial defect, severe dry eye, lacrimal duct defect, glaucoma, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
   4. History of recurrent corneal erosions.
   5. Aphakia.
2. Ocular or systemic allergies or diseases that may interfere with contact lens wear, occur within 2 weeks prior to the Screening Visit.
3. Use of topical ocular medications, except artificial tear, within 7 days prior to the Screening Visit.
4. History of refractive, ocular, or intraocular surgery.
5. Participation in any clinical trial (with the exception of retrospectives studies) within 30 days prior to the Screening Visit.
6. Have risks in dangerous and significant eye edema, congestions, corneal abrasion or neovascularization when wearing contact lens.
7. Any corneal surface roughness.
8. Unable to achieve best corrected visual acuity (BCVA) of logMAR 0.1 or better in each eye at distance using manifest refraction.
9. Females who are pregnant, breastfeeding or who intend to become pregnant over the course of the study.
10. Current drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirement.
11. Allergy to any component in the study product.

12. Subjects who wore monovision, multifocal, toric, or rigid contact lenses within 30 days prior to the Screening Visit.

    Note: Monovision is defined as a vision correction method for treating presbyopia in which the dominant eye is corrected for distance vision and the non-dominant eye is corrected for near vision.

13. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lenses wear at the Investigators discretion within 14 days prior to the Screening Visit.
14. Other conditions not suitable for participating in this study judged by the Investigators.
15. Live in dusty or pharmaceutical environments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ST-1; Subjects will be randomized at Visit 1 with a 2:1 allocation ratio (approximately two-thirds assigned to this arm).	Device: ST-1; ST-1 lens worn in daily wear, daily disposable mode.
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).	Device: Miru 1day UpSide; Miru 1day UpSide lens worn in daily wear, daily disposable mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected distance Logarithm of the Minimum Angle of Resolution (logMAR) visual acuity at the final visit (Visit 7)	Assessed using a Tumbling E Series ETDRS® chart.	Screening, 3 months following enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-assessment of eye symptoms	This questionnaire includes 11 items assessing symptoms during contact lens wear: discomfort, tearing, photophobia, itching, burning, halos, dryness, variable vision, blurred vision, pain, and other (specify if present). Scale: 0-4 (minimum = 0, maximum = 4), where higher scores indicate worse symptoms. Grades: 0 = None; = Trace; = Mild; = Moderate; = Severe	Screening, 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment
Self-assessment of lens performance	This questionnaire includes 5 items assessing lens performance during contact lens wear: insertion comfort, overall comfort, vision, insertion handling, and removal handling. Scale: 0-5 (minimum = 0, maximum = 5), where higher scores indicate worse performance. Grades: 【comfort】 0 = Excellent 1 = Very comfortable 2 = Comfortable 3 = Slightly uncomfortable 4 = Very uncomfortable 5 = Causes pain 【vision】 0 = Excellent; = Very good; = Good; = Poor; = Very poor; = Unacceptable 【handling】 0 = Excellent; = Very good; = Good; = Poor; = Very poor; = Unmanageable	Screening, 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment
Total wearing hours	Cumulative duration of lens wear throughout the study period, determined from the daily wearing time recorded by participants in the electronic patient-reported outcome (ePRO) diary.	Daily for 3 months after enrollment
Total wearing days	Total number of days the study lenses were worn for 8 hours or more, based on the daily wearing time entered by participants in the electronic patient-reported outcome (ePRO) diary. A wearing day is defined as a day with 8 hours or more of lens wear.	Daily for 3 months after enrollment
Average wearing hour each time	Average duration of lens wear for each individual application, derived from the wearing data entered by participants in the electronic patient-reported outcome (ePRO) diary.	Daily for 3 months after enrollment
Daily wearing hour	Average number of hours the study lenses were worn per day, as recorded by participants in the electronic patient-reported outcome (ePRO) diary.	Daily for 3 months after enrollment
Corrected distance visual acuity (CDVA) change with the dispensed lenses from baseline	Assessed using a Tumbling E Series ETDRS® chart.	Screening, 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment
Slit lamp biomicroscopy (SLB) findings	Assessed using a slit lamp.	Screening, 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment
Change from baseline in keratometry readings	To evaluate the absolute change from baseline in keratometry readings between Screening and the 3 months visit.	Screening, 3 months following enrolment
Percent change from baseline in keratometry readings	To evaluate the percent change from baseline in keratometry readings between Screening and the 3-month visit.	Screening, 3 months following enrolment
Change from baseline in refractive parameters	To evaluate the absolute change from baseline in refractive parameters, including sphere (S), cylinder (C), and axis (A), measured by subjective refraction test between Screening and the 3-month visit.	Screening, 3 months following enrolment
Percent change from baseline in refractive parameters	To evaluate the percent change from baseline in refractive parameters, including sphere (S), cylinder (C), and axis (A), measured by subjective refraction test between Screening and the 3-month visit.	Screening, 3 months following enrolment
Adverse events	AE will be evaluated by the investigator.	Screening, 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment
Lens fitting and surface assessment	Lens fitting will be assessed with a slit lamp, and surface assessment will be assessed with a slit lamp or a stereomicroscope.	1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment
Device deficiency	A device deficiency refers to any inadequacy of the investigational product regarding identity, quality, durability, reliability, safety, or performance, including malfunctions, use errors, and labeling issues. Categories include: Failure to meet product specifications (e.g., incorrect lens power/diameter/base curve/color) Lens cloudy or surface/edge defect Torn lens during handling/in pack Packaging deficit (e.g., mislabeled product, tampered seal, leaking container) Suspect contamination Lack of performance (e.g., fit changes under hypobaric or low-humidity conditions) Other If such an event occurs, investigators must evaluate, record, and report all deficiencies and malfunctions during the trial using the device deficiency evaluation form. The frequency of device deficiencies will be summarized for safety evaluation and compared between treatments.	1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment
Overall lens dicontinuation rate	Permanent discontinuation of lens wear, if it occurs, will be recorded via ePRO. The overall discontinuation rate will be calculated and compared between treatments using Chi-square or Fisher's exact test.	Daily for 3 months after enrollment
Lens discontinuation rate by reason	Reasons for permanent discontinuation (e.g., discomfort, adverse event, convenience), if they occur, will be collected via ePRO, categorized, and tabulated by visit and overall.	Daily for 3 months after enrollment
Lens replacement	Lens replacement is defined as removal and reapplication of a lens, regardless of whether a new lens is used. If it occurs, all reasons (e.g., sleeping, rest, device deficiency, adverse events, other) will be recorded via ePRO and tabulated by visit and overall.	Daily for 3 months after enrollment
Artificial tears usage frequency	Participants will record their daily usage of artificial tears via ePRO, if applicable. The record will include both the frequency of use and the number of drops applied each time.	Daily for 3 months after enrollment

Collaborators and Investigators

• Sponsor: Menicon Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Myopia; Soft Contact Lenses; Daily Disposable Soft Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: STCT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No