Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)

Study Overview
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Brief Summary
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The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each

Detailed Description
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The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.

Official Title
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Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)

Conditions
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Myopia

Intervention / Treatment
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* Device: Test Contact Lens
* Device: Control Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears soft contact lenses in daily wear, for minimum of 6-months; Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; Has an astigmatism of ≤ 1.00 D in subjective refraction; Can be fit with study contact lenses with a power between -2.00 and -5.00 DS; Demonstrates an acceptable fit with the study lenses; Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study. Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient; Is aphakic; Has undergone refractive error surgery; Is an employee of the Centre for Ocular Research & Education; Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study; Has participated in any clinical trials within a week prior to the study.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Contact lens<br>Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. | Device: Test Contact Lens<br>* Subjects will be randomized to wear test lenses.<br>* Other names: stenfilcon A;Device: Control Contact Lens<br>* Subjects will be randomized to wear control lenses.<br>* Other names: verofilcon A;|
| Active Comparator: Control Contact Lens<br>Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. | Device: Test Contact Lens<br>* Subjects will be randomized to wear test lenses.<br>* Other names: stenfilcon A;Device: Control Contact Lens<br>* Subjects will be randomized to wear control lenses.<br>* Other names: verofilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Fit Acceptance | Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration | Lens Centration was measured on a scale (0-3) (0 = Optimally centered, 1 = Slightly decentered, 2 = Moderate decentration but not encroaching limbus, 3 = Excessive & occasionally encroaching limbus) | Baseline | 
| Lens Centration | Lens Centration was measured on a scale (0-3) (0 = Optimally centered, 1 = Slightly decentered, 2 = Moderate decentration but not encroaching limbus, 3 = Excessive & occasionally encroaching limbus) | 1 week | 
| Post-blink Movement | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps | Baseline | 
| Post-blink Movement | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps | 1 week | 
| Push-up Tightness | Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | Baseline | 
| Push-up Tightness | Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement) | 1 week |