Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: Acuvue Advance Plus prePQ; Device: Acuvue Advance Plus postPQ

Study type: Interventional

Funder types: Industry

Identifiers

NCT01244893

CR-1636BI

Details and patient eligibility

About

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).

Enrollment: 44 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ

Other group

Description:

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.

Treatment:

Device: Acuvue Advance Plus postPQ

Device: Acuvue Advance Plus prePQ

Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ

Other group

Description:

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.

Treatment:

Device: Acuvue Advance Plus postPQ

Device: Acuvue Advance Plus prePQ