Performance of Two Toric Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.

Detailed Description
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The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.

Official Title
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Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear

Conditions
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Astigmatism

Intervention / Treatment
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* Device: fanfilcon A toric lens
* Device: senofilcon A toric lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted soft contact lens wearer Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive) Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes. Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit schedule Exclusion Criteria: Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the 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
Maximum Age: 40 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
Interventional Model Description: Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fanfilcon A toric lens<br>Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. | Device: fanfilcon A toric lens<br>* contact lens<br>* Other names: Avaira Vitality toric lens;|
| Active Comparator: senofilcon A toric lens<br>Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. | Device: senofilcon A toric lens<br>* contact lens<br>* Other names: Acuvue Oasys for Astigmatism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | Baseline | 
| Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | 2 weeks | 
| Corneal Coverage | Lens covering the cornea (Yes, No) | Baseline | 
| Corneal Coverage | Lens covering the cornea (Yes, No) | 2 weeks | 
| Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | Baseline | 
| Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearing Time | Average daily wearing time (hours/day) | 2 weeks | 
| Comfortable Wearing Time | Comfortable daily wearing time (hours/day) | 2 weeks |