Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses

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 verofilcon A to somofilcon A 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 somofilcon A (test lens) and verofilcon A (control lens).

Official Title
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Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: somofilcon A
* Device: verofilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - A person is eligible for inclusion in the study if he/she: 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: - A person may be excluded from the study if he/she: 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 MIKI (EX-MKTG-114) 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: somofilcon A<br>Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week. | Device: somofilcon A<br>* Subjects will be randomized to wear somofilcon A daily disposable lenses.<br>* Other names: Clariti 1 Day;|
| Active Comparator: verofilcon A<br>Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. | Device: verofilcon A<br>* Subjects will be randomized to wear verofilcon A daily disposable lenses.<br>* Other names: Precision 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ratings for Lens Handling for Lens Insertion | Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy). | 1 week | 
| Subjective Ratings for Lens Handling for Lens Removal | Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy). | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit - Centration | Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus) | Baseline | 
| Lens Fit - Centration | Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus) | 1-week | 
| Lens Fit - 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 | 
| Lens Fit - 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 | 
| Lens Fit - Lens Push-up Tightness | The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement | Baseline | 
| Lens Fit - Lens Push-up Tightness | The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement | 1-week |