Pilot Dispensing Evaluation of a Plus Power Lens

NCT ID: NCT01228591

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2010-11-30

Brief Summary

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.

Conditions

Hyperopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acuvue Advance Plus/ Acuvue Advance

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

Group Type: OTHER

Acuvue Advance Plus

Intervention Type: DEVICE

Silicone hydrogel contact lens.

Acuvue Advance

Intervention Type: DEVICE

Silicone hydrogel contact lens

Acuvue Advance/Acuvue Advance Plus

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

Group Type: OTHER

Acuvue Advance Plus

Intervention Type: DEVICE

Silicone hydrogel contact lens.

Acuvue Advance

Intervention Type: DEVICE

Silicone hydrogel contact lens

Interventions

Acuvue Advance Plus

Silicone hydrogel contact lens.

Intervention Type: DEVICE

Acuvue Advance

Silicone hydrogel contact lens

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Winter Park, Florida, United States

New York, New York, United States

Nanticoke, Pennsylvania, United States

Countries

United States

Other Identifiers

CR-1636BB

Identifier Type: -

Identifier Source: org_study_id