Senofilcon A Investigational Manufacturing Process

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of a new contact lens hydration process

Detailed Description
-----------------
To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.

Official Title
-----------------
Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process

Conditions
-----------------
Comfort, Visual Acuity, Overall Vision

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be at least 18 and not more than 70 years of age. The subject's refractive cylinder must be < 0.75D in each eye. The subject must have best corrected visual acuity of 20/25 or better in each eye. The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes. The subject must have normal eyes (i.e., no ocular medications or infections of any type). The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye. Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Monovision or multi-focal contact lens correction. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. History of binocular vision abnormality or strabismus. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report). Suspicion of or recent history of alcohol or substance abuse. History of serious mental illness. History of seizures. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control, senofilcon A<br>Subjects received Control lens, senofilcon A during the first two weeks of the study then Test lens, senofilcon A in the last two weeks of the study. | Device: senofilcon A<br>* Control, senfilcon A<br>|
| Experimental: Test, senofilcon A<br>Subjects received Test lens, senofilcon A during the first two weeks of the study then Control lens, senofilcon A in the last two weeks of the study. | Device: senofilcon A<br>* Test, senofilcon A<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Comfort (Using CLUE ) | Contact Lens User Experience Comfort scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | 2 weeks | 
| Subjective Overall Vision (Using CLUE ) | Contact Lens User Experience Vision scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | 2 weeks |