Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

Study Overview
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Brief Summary
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The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Official Title
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A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism

Conditions
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Astigmatism

Intervention / Treatment
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* Device: comfilcon A toric lens
* Device: samfilcon A toric lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has had a self-reported oculo-visual examination in the last two years. Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day. Is willing to wear contact lens in both eyes for the duration of the study; Has a minimum astigmatism of - 0.75, determined by refraction; Can be fit with the two study contact lens types in the powers available; Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction; Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses. Has clear corneas and no active* ocular disease Exclusion Criteria: Is participating in any concurrent clinical trial; Has any known active* ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study measure; Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure; Has known sensitivity to fluorescein dye or products to be used in the study; Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses; Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); Is aphakic; Has undergone refractive error surgery. Has participated in the PIANO (i.e. EX-MKTG-83) Study.

Ages Eligible for Study
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Minimum Age: 17 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comfilcon A toric lens<br>Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study. | Device: comfilcon A toric lens<br>* Contact lens<br>* Other names: test lens;Device: samfilcon A toric lens<br>* Contact lens<br>* Other names: control lens;|
| Active Comparator: samfilcon A toric lens<br>Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study. | Device: comfilcon A toric lens<br>* Contact lens<br>* Other names: test lens;Device: samfilcon A toric lens<br>* Contact lens<br>* Other names: control lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort at Insertion | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | Dispense | 
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | 2 weeks | 
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens) | 1-month | 
| Lens Preference Based on Overall Comfort | Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference) | 1 month | 
| Lens Preference Based on Overall Dryness | Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference) | 1 month | 
| Dryness | Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness) | 2 weeks | 
| Dryness | Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness) | 1-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | Dispense | 
| Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | 2-weeks | 
| Ease of Insertion | Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy) | 1-month | 
| Ease of Removal | Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy) | 2-weeks | 
| Ease of Removal | Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy) | 1 month |