Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

Study Overview
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Brief Summary
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The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Detailed Description
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The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

Official Title
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Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Device: comfilcon A Toric


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has had an oculo-visual examination in the last two years Is at least 18 years of age and has full legal capacity to volunteer Has read and understood the information consent letter Is willing and able to follow instructions and maintain the appointment schedule Is correctable to a visual acuity of 20/50 or better (in at least one eye) Currently wears soft toric contact lenses in both eyes Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye: -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25 +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25 -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75 -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75 +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75 Has clear corneas and no active ocular disease Demonstrates an acceptable fit with the study lenses Exclusion Criteria: Has never worn contact lenses before; Has any systemic disease affecting ocular health; Is using any systemic or topical medications that will affect ocular health; Has any ocular pathology or abnormality that would affect the wearing of 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

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comfilcon A toric<br>Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Device: comfilcon A Toric<br>* Contact lenses<br>* Other names: Biofinity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 
| Overall Vision | Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time. | 2 weeks prior to baseline, Baseline, 2 weeks post | 
| Handling | Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 
| Overall Satisfaction | Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 
| Lens Fit - Rotation | Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 
| Lens Fit - Overall Stability | Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 
| Lens Fit Acceptance | General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum) | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 
| Anterior Ocular Health - Palpebral Hyperemia and Roughness | Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe | Baseline and 2 weeks | 
| Anterior Ocular Health - Bulbar and Limbal Redness | Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection | Baseline and 2 weeks | 
| Anterior Ocular Health - Corneal Staining | Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area | Baseline and 2 weeks | 
| Anterior Ocular Health - Conjunctival Staining and Indentation | Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe | Baseline and 2 weeks | 
| Visual Acuity | Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR. | 2 weeks prior to baseline, Baseline, 2 weeks post baseline | 
| Subjective Preference - Comfort | Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks | 
| Preference - Vision | Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks | 
| Preference - Handling | Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks | 
| Overall Preference | Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses | Baseline and 2 weeks | 
| Investigator Acceptability | Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree. | Baseline and 2 weeks |