Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

Study Overview
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Brief Summary
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This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Conditions
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Astigmatism

Intervention / Treatment
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* Device: senofilcon A toric
* Device: galyfilcon A toric


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to wear study lenses in parameters available. At least 18 understand and sign informed consent willing to follow the protocol achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180 oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months Exclusion Criteria: Any ocular or systemic disorder which may contraindicate Contact Lens (CL) 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

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: senofilcon A/galyfilcon A<br>senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second. | Device: senofilcon A toric<br>* silicone hydrogel contact lens for patients with astigmatism<br>* Other names: Acuvue Oasys for Astigmatism;Device: galyfilcon A toric<br>* silicone hydrogel contact lens for patients with astigmatism<br>* Other names: Acuvue Advance for Astigmatism;|
| Active Comparator: galyfilcon A/senofilcon A<br>galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second. | Device: senofilcon A toric<br>* silicone hydrogel contact lens for patients with astigmatism<br>* Other names: Acuvue Oasys for Astigmatism;Device: galyfilcon A toric<br>* silicone hydrogel contact lens for patients with astigmatism<br>* Other names: Acuvue Advance for Astigmatism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear | 
| Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |