Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Study Overview
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Brief Summary
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Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

Detailed Description
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The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.

Official Title
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Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Conditions
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Myopia

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


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 between 18 and 40 years of age (inclusive) Has read, understood and signed the information consent letter Has had a self-reported eye exam in the last two years Is a spherical soft contact lens wearer Has a contact lens prescription that fits within the available parameters of the study lenses Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye 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 Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear) Is willing and able to follow instructions and maintain the appointment schedule Exclusion Criteria: A person will be excluded from the study if he/she: Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; >8 hours/day) Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses Is habitually using rewetting/ lubricating eye drops more than once per day Presents with clinically significant anterior segment abnormalities Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear Presents with slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Significant 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 (or history in past year) Seborrheic eczema of eyelid region, 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

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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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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fanfilcon A<br>Participants are randomized to wear fanfilcon A for two weeks during the cross over study. | Device: fanfilcon A<br>* contact lens<br>|
| Active Comparator: senofilcon A<br>Participants are randomized to wear senofilcon A for two weeks during the cross over study. | Device: senofilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel | 2 weeks | 
| Overall Dryness | Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness | 2 weeks | 
| Vision Quality | Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear | 2 weeks | 
| Lens Handling | Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle | 2 weeks | 
| Vision Satisfaction | Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied. | 2 weeks | 
| Lens Centration | Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable). | 2 weeks | 
| Conjunctival Staining | Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present Very slight Slight Moderate Severe | 2 weeks | 
| Smoothness | Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth | 2 weeks | 
| Clean Feeling | Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean | 2 weeks | 
| Lens Hydrated | Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated | 2 weeks | 
| Lens Wettability | Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable | 2 weeks |