A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

Study Overview
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Brief Summary
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The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

Detailed Description
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This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.

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

Conditions
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Astigmatism Bilateral

Intervention / Treatment
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* Device: Comfilcon A (test)
* Device: Senofilcon C (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: 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: A person will be excluded from the study if he/she: 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 previous QUENA 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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Accepts Healthy Volunteers

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
Interventional Model Description: Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comfilcon A (test)<br>Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. | Device: Comfilcon A (test)<br>* Daily wear contact lenses<br>Device: Senofilcon C (control)<br>* Daily wear contact lenses<br>|
| Active Comparator: Senofilcon C (control)<br>Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study. | Device: Comfilcon A (test)<br>* Daily wear contact lenses<br>Device: Senofilcon C (control)<br>* Daily wear contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Insertion(Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | Baseline | 
| Ease of Insertion (Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | 2 weeks | 
| Ease of Insertion(Handling) | Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational Recovery After Lens Mislocation | Lens relocation after 10 blinks, after 30º rotation mislocation | Baseline | 
| Rotational Recovery After Lens Mislocation | Lens relocation after 10 blinks, after 30º rotation mislocation. | 1 month |