One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.

Detailed Description
-----------------
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month. Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.

Official Title
-----------------
One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: comfilcon A sphere lens (control)
* Device: comfilcon A asphere lens (test)


Participation Criteria
=================
Eligibility Criteria
-----------------
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 an adapted comfilcon A sphere contact lens wearer Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week. 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 refraction that fits 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 A person will be excluded from the study if he/she: Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comfilcon A asphere (test)<br>Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). | Device: comfilcon A asphere lens (test)<br>* contact lens<br>|
| Active Comparator: comfilcon A sphere (control)<br>Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). | Device: comfilcon A sphere lens (control)<br>* contact lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit - Centration | Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable). | baseline, 2 weeks, 1 month | 
| Lens Fit - Corneal Coverage | Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage). | baseline, 2 weeks, 1 month | 
| Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | baseline, 2 weeks, 1 month | 
| Lens Preference/Acceptability | Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses). | baseline, 2 weeks, 1 month |