Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

Study Overview
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Brief Summary
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The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

Detailed Description
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The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.

Official Title
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Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

Conditions
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Myopia

Intervention / Treatment
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* Device: somofilcon A contact lens
* Device: fanfilcon A contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted soft contact lens wearer Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive) Have no less than -0.75D of astigmatism in both eyes. Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit schedule Exclusion Criteria: Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder of ≥ 1.00D in either eye. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somofilcon A (habitual) lens, then fanfilcon A (test) lens<br>Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens. | Device: somofilcon A contact lens<br>* Contact Lens<br>* Other names: Habitual lens;Device: fanfilcon A contact lens<br>* Contact Lens<br>* Other names: Test lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration for Somofilcon A (Habitual) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Lens Centration for Somofilcon A (Habitual) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4- weeks | 
| Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2-weeks | 
| Lens Centration for Fanfilcon A (Test) Lens | Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4- weeks | 
| Lens Corneal Coverage for Somofilcon A (Habitual) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline | 
| Lens Corneal Coverage for Somofilcon A (Habitual) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 4 -weeks | 
| Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline | 
| Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 2-weeks | 
| Lens Corneal Coverage for Fanfilcon A (Test) Lens | Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 4-weeks | 
| Percentage of Lens Tightness for Somofilcon A (Habitual) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Baseline | 
| Percentage of Lens Tightness for Somofilcon A (Habitual) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | 4-Weeks | 
| Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | Baseline | 
| Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | 2-Weeks | 
| Percentage of Lens Tightness for Fanfilcon A (Test) Lens | Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement) | 4-Weeks | 
| Post-Blink Movement for Somofilcon A (Habitual) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Baseline | 
| Post-Blink Movement for Somofilcon A (Habitual) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | 4-weeks | 
| Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | Baseline | 
| Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | 2-weeks | 
| Post-Blink Movement for Fanfilcon A (Test) Lens | Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement) | 4-weeks | 
| Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Baseline | 
| Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | 4-weeks | 
| Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | Baseline | 
| Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | 2-weeks | 
| Overall Lens Fit Acceptance for Fanfilcon A (Test) Lens | Overall fit acceptance was measured using a scale of 0-4 (0= should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect) | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Wearing Time - Somofilcon A (Habitual) Lens | Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day | 4-weeks | 
| Average Daily Wearing Time - Fanfilcon A (Test) Lens | Average daily wearing time for fanfilcon A (test) lens was measured in hours/day | 2-weeks | 
| Average Daily Wearing Time - Fanfilcon A (Test) Lens | Average daily wearing time for fanfilcon A (test) lens was measured in hours/day | 4-weeks | 
| Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens | Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | 4 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A (Test) Lens | Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | 2 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A (Test) Lens | Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation. | 4 weeks |