Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical 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 somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

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

Official Title
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Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)

Conditions
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Myopia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will only be eligible for the study if: 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 silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months; Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS; Demonstrates an acceptable fit with the study lenses; Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study. Exclusion Criteria: Subjects will not be eligible to take part in the study if: 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 (verbal confirmation at the screening visit); Is aphakic; Has undergone refractive error surgery; Is an employee of the Centre for Ocular Research & Education; Has participated in the BEAGLE (EX-MKTG-104) 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 etafilcon A daily disposable lenses for one week. | Device: somofilcon A<br>* Contact Lens<br>* Other names: Clariti 1-Day;|
| Active Comparator: etafilcon A<br>Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. | Device: etafilcon A<br>* Contact Lens<br>* Other names: 1-Day Acuvue Moist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 1 | 
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 3 | 
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 5 | 
| Lens Handling for Lens Insertion | Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | 1 Week | 
| Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 1 | 
| Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 3 | 
| Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | Day 5 | 
| Lens Handling for Lens Removal | Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration | Lens 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 (after 10 minutes of lens fitting) | 
| Lens Centration | Lens 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 | 
| Post-blink Movement | Post-blink movement in primary gaze, in 0.1mm steps | Baseline (after 10 minutes of lens fitting) | 
| Post-blink Movement | Post-blink movement in primary gaze, in 0.1mm steps | 1 -week | 
| Push-up Tightness | Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | Baseline (after 10 minutes of lens fitting) | 
| Push-up Tightness | Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | 1 week |