MyopiaNCT07345416
A Clinical Trial Assessing the Efficacy and Safety of ST-1 Silicone Hydrogel Daily Disposable Soft Contact Lenses Compared to Miru 1day UpSide
A study testing ST-1 and Miru 1day UpSide in people with Myopia and Soft Contact Lenses, run by Menicon Co., Ltd. at 6 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Soft Contact Lenses, Daily Disposable Soft Contact Lenses
- What is being tested?
- ST-1 and Miru 1day UpSide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 6 sitesTaiwan
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- With either gender aged between 18 to 40 (inclusive) years old.
- Diagnosis of myopia in both eyes, each ranging from -0.50D to 6.00D with manifest astigmatism of ≤ 1.00D per eye.
- Understands and signs an informed consent form (ICF).
- Willing to adhere to the instructions set forth in this study as well as understand and complete all specified evaluation.
- Willing and able to refrain from using any other contact lenses other than those provided for the duration of the study.
- Has experience and capability of wearing soft contact lenses.
- 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.
- Tear breakup time (TBUT) > 5 seconds in each eye.
Who cannot join
- Eyes with abnormality or disease as follows:
- Evidence of lid abnormality or infection (e.g., entropion, ectropion, chalazia, and recurrent styes).
- Clinically significant slit lamp findings (e.g., infiltrates or other slit lamp findings Level 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
- 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).
- History of recurrent corneal erosions.
- Aphakia.
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- Ocular or systemic allergies or diseases that may interfere with contact lens wear, occur within 2 weeks prior to the Screening Visit.
- Use of topical ocular medications, except artificial tear, within 7 days prior to the Screening Visit.
- History of refractive, ocular, or intraocular surgery.
- Participation in any clinical trial (with the exception of retrospectives studies) within 30 days prior to the Screening Visit.
- Have risks in dangerous and significant eye edema, congestions, corneal abrasion or neovascularization when wearing contact lens.
- Any corneal surface roughness.
- Unable to achieve best corrected visual acuity (BCVA) of logMAR 0.1 or better in each eye at distance using manifest refraction.
- Females who are pregnant, breastfeeding or who intend to become pregnant over the course of the study.
- Current drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirement.
- Allergy to any component in the study product.
- 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.
- 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.
- Other conditions not suitable for participating in this study judged by the Investigators.
- Live in dusty or pharmaceutical environments.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Taiwan6 sites
Changhua Christian Hospital
Changhua, Changhua City, 50006
Jian-Sheng Wu, +886-4-723-8595, 125181@cch.org.tw
Jian-Sheng Wu
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung City, 80756
Shiuh-Liang Hsu, +886-7-312-1101, shiuhlianghsu@gmail.com
Shiuh-Liang Hsu
Far Eastern Memorial Hospital
New Taipei City, New Taipei City, 220
Tzu-Yun Tsai, +886-2-8966-7000, ceciliatsai1978@gmail.com
Tzu-Yun Tsai
Taipei Veterans General Hospital
Taipei, Taipei City, 11217
Tri-Service General Hospital
Taipei, Taipei City, 114202
Tzu-Heng Weng, +886-2-8792-3311, Aheng7435@gmail.com
Tzu-Heng Weng
Chang-Gung Memorial Hospital LinKou Branch
Taoyuan, Taoyuan City, 33305
Yu-Chuan Kang, +886-3-328-1200, yckang0321@gmail.com
Yu-Chuan Kang
About this study
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
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).
- Being tested
- ST-1, Miru 1day UpSide
- Keywords
- Myopia, Soft Contact Lenses, Daily Disposable Soft Contact Lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-1Device
ST-1 lens worn in daily wear, daily disposable mode.
Miru 1day UpSideDevice
Miru 1day UpSide lens worn in daily wear, daily disposable mode.
| Study group | Role | What they receive |
|---|---|---|
| ST-1 | Experimental | Subjects will be randomized at Visit 1 with a 2:1 allocation ratio (approximately two-thirds assigned to this arm). Receives: Device: ST-1 |
| Miru 1day UpSide | Active comparator | Subjects will be randomized at Visit 1 with a 2:1 allocation ratio (approximately one-third assigned to this arm). Receives: Device: Miru 1day UpSide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, 3 months following enrolment
Secondary outcomes (19)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening, 3 months following enrolment
Adverse events
AE will be evaluated by the investigator.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily for 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menicon Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345416
- Sponsor's protocol ID
- STCT-01
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No