Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

Study Overview
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Brief Summary
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The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

Detailed Description
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The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear. This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).

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

Conditions
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Astigmatism

Intervention / Treatment
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* Device: somofilcon A toric contact lens
* Device: fanfilcon A toric 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 toric contact lens wearer Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive) Have no less than -0.75D of astigmatism and no more than -2.25 D 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 less than -0.75D or more than -2.50 D of cylinder 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) 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 toric (habitual), then fanfilcon toric (test)<br>Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. | Device: somofilcon A toric contact lens<br>* Contact Lens<br>* Other names: Habitual lens;Device: fanfilcon A toric 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 - Somofilcon A Toric (Habitual) Lens | Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Lens Centration - Somofilcon A Toric (Habitual) Lens | Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks | 
| Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2-weeks | 
| Lens Centration - Fanfilcon A Toric Lens | Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4-weeks | 
| Corneal Coverage - Somofilcon A Toric (Habitual ) Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline | 
| Corneal Coverage - Somofilcon A Toric (Habitual ) Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 4-weeks | 
| Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | Baseline | 
| Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 2-weeks | 
| Corneal Coverage - Fanfilcon A Toric Lens | Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage) | 4-weeks | 
| Post-Blink Movement - Somofilcon A Toric (Habitual) Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement) | Baseline | 
| Post-Blink Movement - Somofilcon A Toric (Habitual) Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4-weeks | 
| Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Baseline | 
| Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 2-weeks | 
| Post-Blink Movement - Fanfilcon A Toric Lens | Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4-weeks | 
| Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens | Overall fit acceptance - using a 0 - 4 scale (where 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 - Somofilcon A Toric (Habitual) Lens | Overall fit acceptance - using a 0 - 4 scale (where 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 - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 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 - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 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 - Fanfilcon A Toric Lens | Overall fit acceptance - using a 0 - 4 scale (where 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 Toric (Habitual) Lens | Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day. | 4 weeks | 
| Average Daily Wearing Time - Fanfilcon A Toric Lens | Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day. | 2 weeks | 
| Average Daily Wearing Time - Fanfilcon A Toric Lens | Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day. | 4 weeks | 
| Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens | Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day | 4 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A Toric Lens | Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day. | 2 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A Toric Lens | Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day. | 4 weeks |