Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).

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

Intervention / Treatment
-----------------
* Device: Acuvue Advance Plus prePQ
* Device: Acuvue Advance Plus postPQ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must be at least 18 years of age and no more than 39 years of age. The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day). The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D. Any cylinder power must be ≤ -0.75D. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. The subject must read and sign the Statement of Informed Consent. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Ocular or systemic allergies or disease which might interfere with contact lens wear. Systemic disease or use of medication which might interfere with contact lens wear. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation. Diabetes. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). Habitual contact lens type is toric, multifocal, or is worn as extended wear.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ<br>Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second. | Device: Acuvue Advance Plus prePQ<br>* silicone hydrogel contact lens manufactured prior to equipment process qualification activities.<br>Device: Acuvue Advance Plus postPQ<br>* silicone hydrogel contact lens manufactured after equipment process qualification activities.<br>|
| Other: Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ<br>Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second. | Device: Acuvue Advance Plus prePQ<br>* silicone hydrogel contact lens manufactured prior to equipment process qualification activities.<br>Device: Acuvue Advance Plus postPQ<br>* silicone hydrogel contact lens manufactured after equipment process qualification activities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (VA) | Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result. | 6-8 days after lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining | Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | 6-8 days after lens wear | 
| Limbal Redness | Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | 6-8 days after lens wear | 
| Bulbar Redness | Scale of 0 increasing to 4. 0=None, 4=Severe Redness | 6-8 days after lens wear |