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

N/ANot Yet RecruitingNCT07345416

Menicon Co., Ltd.63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia Soft Contact Lenses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Screening, 3 months following enrolment

Secondary Outcomes

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 1. = Trace 2. = Mild 3. = Moderate 4. = Severe

Time frame: 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 1. = Very good 2. = Good 3. = Poor 4. = Very poor 5. = Unacceptable 【handling】 0 = Excellent 1. = Very good 2. = Good 3. = Poor 4. = Very poor 5. = Unmanageable

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Screening, 3 months following enrolment

Adverse events

AE will be evaluated by the investigator.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Daily for 3 months after enrollment

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes