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

NCT07345416 | Not Yet Recruiting

• 1 other identifier: STCT-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Soft Contact Lenses; Daily Disposable Soft Contact Lenses; Myopia

Keywords

Myopia; Soft Contact Lenses; Daily Disposable Soft Contact Lenses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Self-assessment of eye symptoms

  Screening, 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment

• Self-assessment of lens performance

  Screening, 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months following enrolment

• Total wearing hours

  Daily for 3 months after enrollment

• Total wearing days

  Daily for 3 months after enrollment

• Average wearing hour each time

  Daily for 3 months after enrollment

Study Arms (2)

ST-1

EXPERIMENTAL

Subjects will be randomized at Visit 1 with a 2:1 allocation ratio (approximately two-thirds assigned to this arm).

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).

Device: Miru 1day UpSide

Interventions

ST-1 DEVICE

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

ST-1

Miru 1day UpSide DEVICE

Miru 1day UpSide lens worn in daily wear, daily disposable mode.

Miru 1day UpSide

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Menicon Co., Ltd.: lead

Study Sites (6)

Changhua Christian Hospital

Changhua, Changhua City, 50006, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung City, 80756, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, New Taipei City, 220, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taipei City, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, Taipei City, 114202, Taiwan

Location

Chang-Gung Memorial Hospital LinKou Branch

Taoyuan District, Taoyuan City, 33305, Taiwan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and evaluators will be masked to the treatment assignment of the randomization code. Each site must have an unmasked staff member who will be responsible for dispensing and collecting the study test and control lenses. The randomization code will be provided to this unmasked staff member at the time of subject randomization. Although this design involves masking of both investigators and evaluators, the official protocol title refers to the study as "Single-Masked" because the subjects are not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)