Performance Comparison Between Comfilcon A and Senofilcon C Lenses

Study Overview
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Brief Summary
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The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Detailed Description
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This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Official Title
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Performance Comparison Between Comfilcon A and Senofilcon C Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: comfilcon A
* Device: senofilcon C


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 34 years of age (inclusive) Has had a self-reported eye exam in the last two years Is a spherical soft contact lens wearer Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive) 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 Has read, understood and signed the information consent letter. Has a contact lens prescription that fits within the available parameters of the study lenses. Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit 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 6 days per week; > 10 hours/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. Is participating in any other type of eye related clinical or research study. Is habitually using rewetting/ lubricating eye drops more than once per day Is currently wearing daily disposable lenses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 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: comfilcon A<br>Participants are randomized to wear the comfilcon A lens for one month during the cross over study. | Device: comfilcon A<br>* contact lens<br>|
| Active Comparator: senofilcon C<br>Participants are randomized to wear the senofilcon C lens for one month during the cross over study. | Device: senofilcon C<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Fit Acceptance | Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect. | Up to 1 month | 
| Corneal Coverage | Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no) | Up to 1 month | 
| Lens Centration | Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable) | Up to 1 month | 
| Post-blink Movement | Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement) | Up to 1 month | 
| Lens Lag at Primary Gaze | Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size) | Up to 1 month | 
| Tightness on Push up | Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement) | Up to 1 month | 
| Lens Wettability | Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent) | Up to 1 month | 
| Deposit Grading | Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits) | Up to 1 month |