Pilot Dispensing Evaluation of a Plus Power Lens

Johnson & Johnson (J&J)

Status: Completed

Conditions: Hyperopia

Treatments: Device: Acuvue Advance Plus; Device: Acuvue Advance

Study type: Interventional

Funder types: Industry

Identifiers

NCT01228591

CR-1636BB

Details and patient eligibility

About

The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Enrollment: 38 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject must be at least 18 years of age and no more than 45 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 (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
• The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
• 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 the 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, bifocal, in monovision contact lens wear, or is worn as extended wear.
• Need any near correction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

Acuvue Advance Plus/ Acuvue Advance

Other group

Description:

Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.

Treatment:

Device: Acuvue Advance Plus

Device: Acuvue Advance

Acuvue Advance/Acuvue Advance Plus

Other group

Description:

Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.

Treatment:

Device: Acuvue Advance Plus

Device: Acuvue Advance