Clinical Performance of Senofilcon A Investigational Lens

Study Overview
=================
Brief Summary
-----------------
This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.

Official Title
-----------------
Clinical Performance of Senofilcon A Investigational Lens

Conditions
-----------------
Visual Acuity

Intervention / Treatment
-----------------
* Device: senofilcon A prototype
* Device: Dailies Total 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must: Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be between 18 and 39 (inclusive) years of age at the time of screening. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily wear or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study. Possess a wearable pair of spectacles that provide correction for distance vision. Inclusion Criteria at Baseline Evaluation The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye. The best corrected, monocular, distance visual acuity must be 20/25or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Exclusion Criteria after Screening The subject must not: Be currently pregnant or lactating. Be currently using any ocular medications or have any ocular infection of any type. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. Be currently wearing monovision or multifocal contact lenses. Be currently wearing lenses in an extended wear modality. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. Exclusion Criteria at Baseline Evaluation The subject must not: Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). (Specify method of determination if needed). Have a history of strabismus or amblyopia. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEST LENS<br>Eligible subjects who are habitual soft contact lens wearers will be randomly assigned the TEST Lens for the duration of the study. | Device: senofilcon A prototype<br>* Test<br>|
| Experimental: CONTROL LENS<br>Eligible subjects who are habitual soft contact lens wearers will be randomly assigned the CONTROL Lens for the duration of the study. | Device: Dailies Total 1<br>* Control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Day Comfort | End of day comfort was assessed using an individual item Comfort at the End of the Day. Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied. | 2-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital Device Use | Lens performance in digital device use was assessed using an individual item Reduction in the feeling of tired eyes from using a computer or other digital device. Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. Not Applicable was excluded from the analysis. | 2-Week Follow-up | 
| Comfort Throughout the Day | Comfort throughout the day was measured using an individual item I could wear these contact lenses comfortably for as long as I wanted to. Response set: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. | 2-Week Follow-up | 
| Comfortable Vision While Night Driving | Comfortable vision while night driving was assessed using an individual item Ability to see comfortably while driving at night. Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. Not Applicable was excluded from the analysis. | 2-Week Follow-up |