Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Study Overview
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Brief Summary
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To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.

Official Title
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Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Conditions
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Astigmatism

Intervention / Treatment
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* Device: senofilcon A toric contact lens
* Device: balafilcon A toric contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to wear study lenses in parameters available Non-presbyopes between the ages of 18-45 Understand and sign informed consent Willing to follow the protocol Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10) Adapted soft contact lens wearer Swims no more than once a week Has a wearable pair of spectacles. Exclusion Criteria: Any ocular or systemic disorder which may contraindicate contact lens wear Any topical ocular medication Aphakic Corneal refractive surgery Corneal distortion from hard CL wear or keratoconus Pregnant or lactating Grade 2 or worse slit lamp signs Infectious disease Previous clinical study within 2 weeks Don't agree to participate Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks Previous adverse effects that contraindicate extended lens wear. Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: senofilcon A toric bilaterally<br>senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. | Device: senofilcon A toric contact lens<br>* soft contact lens<br>|
| Active Comparator: balafilcon A toric bilaterally<br>balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. | Device: balafilcon A toric contact lens<br>* soft contact lens<br>|
| Active Comparator: senofilcon A/balafilcon A contralaterally<br>senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. | Device: senofilcon A toric contact lens<br>* soft contact lens<br>Device: balafilcon A toric contact lens<br>* soft contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) | 
| Limbal Redness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) | 
| Bulbar Redness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) | 
| Tarsal Roughness | Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally. | at 3 months of lens wear (period 1) |