Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

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 methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Official Title
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Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

Conditions
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Ametropia

Intervention / Treatment
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* Device: methafilcon A contact lenses
* Device: fanfilcon A contact lenses


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 (Diopter) 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 Contact Lens (CL) prescription outside the range of the available parameters of the study lenses Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye Has a history of not achieving comfortable Contact Lens (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

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methalfilcon A contact lenses / fanfilcon A contact lenses<br>All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. | Device: methafilcon A contact lenses<br>* Bilateral daily wear of methafilcon A contact lenses<br>Device: fanfilcon A contact lenses<br>* Bilateral daily wear of fanfilcon A contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks | 
| Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2 weeks | 
| Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks | 
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Baseline | 
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | 4 weeks | 
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Baseline | 
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | 2 weeks | 
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | 4 weeks | 
| Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Methafilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 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 Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 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 | 
| Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Baseline | 
| Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | 4 weeks | 
| Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Baseline | 
| Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | 2 weeks | 
| Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | 4 weeks | 
| Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Baseline | 
| Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | 4 weeks | 
| Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Baseline | 
| Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | 2 weeks | 
| Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Wearing Time - Methafilcon A Contact Lenses | Average daily wearing time response by the subject | 4 weeks | 
| Average Daily Wearing Time - Fanfilcon A Contact Lenses | Average daily wearing time response by the subject. | 2 weeks | 
| Average Daily Wearing Time - Fanfilcon A Contact Lenses | Average daily wearing time response by the subject | 4 weeks | 
| Average Comfortable Wearing Time - Methafilcon A Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A Contact Lenses | Average comfortable wearing time - response by the subject | 2 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks |