Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

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 toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.

Official Title
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Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

Conditions
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Ametropia

Intervention / Treatment
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* Device: methafilcon A toric contact lenses
* Device: fanfilcon A toric 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 +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 Contact Lens (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 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 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
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks | 
| Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline | 
| Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2 weeks | 
| Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4 weeks | 
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Baseline | 
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | 4 weeks | 
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Baseline | 
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | 2 weeks | 
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | 4 weeks | 
| Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Baseline | 
| Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | 4 weeks | 
| Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Baseline | 
| Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | 2 weeks | 
| Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | 4 weeks | 
| Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Baseline | 
| Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | 4 weeks | 
| Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Baseline | 
| Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | 2 weeks | 
| Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | 4 weeks | 
| Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Average daily wearing time response by the subject | 4 weeks | 
| Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses | Average daily wearing time response by the subject | 2 weeks | 
| Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses | Average daily wearing time response by the subject | 4 weeks | 
| Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | 2 weeks | 
| Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks |