Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

Not Applicable

Completed

Interventions: Device: Acuvue Advance Plus prePQ
Device: Acuvue Advance Plus postPQ

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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ	Acuvue Advance Plus postPQ	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.
Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ	Acuvue Advance Plus prePQ	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.
Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ	Acuvue Advance Plus postPQ	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.
Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ	Acuvue Advance Plus prePQ	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.

Primary Outcome Measures

Name	Time	Method
Visual Acuity (VA)	6-8 days after lens wear	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.

Secondary Outcome Measures

Name	Time	Method
Limbal Redness	6-8 days after lens wear	Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Bulbar Redness	6-8 days after lens wear	Scale of 0 increasing to 4. 0=None, 4=Severe Redness
Corneal Staining	6-8 days after lens wear	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.