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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST-1 | Experimental | Subjects will be randomized at Visit 1 with a 2:1 allocation ratio (approximately two-thirds assigned to this arm). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST-1 | Device | ST-1 lens worn in daily wear, daily disposable mode. |
| |
| 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 |
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
Eyes with abnormality or disease as follows:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Changhua City | 50006 | Taiwan |
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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.
| Miru 1day UpSide |
| Device |
Miru 1day UpSide lens worn in daily wear, daily disposable mode. |
|
| 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
0 = Excellent
| 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 |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Kaohsiung City | 80756 | Taiwan |
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| Far Eastern Memorial Hospital | New Taipei City | New Taipei City | 220 | Taiwan |
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| Taipei Veterans General Hospital | Taipei | Taipei City | 11217 | Taiwan |
| Tri-Service General Hospital | Taipei | Taipei City | 114202 | Taiwan |
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| Chang-Gung Memorial Hospital LinKou Branch | Taoyuan | Taoyuan City | 33305 | Taiwan |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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