ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry

Johnson & Johnson (J&J)

Status: Completed

Conditions: Vision Satisfaction in Bright Light

Treatments: Device: Silicone Hydrogel Contact Lens; Device: ACUVUE® OASYS with Transitions™

Study type: Observational

Funder types: Industry

Identifiers

NCT04116736

CR-6334

Details and patient eligibility

About

This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

• Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses.
• A minimum age of 18 years, with no maximum age.
• The registrant must read and sign the Informed Consent form.
• The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

• Current participant in another research study.
• Employee or relative of site, or family member of Recruiting Practitioner or Johnson & Johnson.
• Non-spherical contact lens wearers, i.e. toric or multifocal lenses.

Trial design

146 participants in 2 patient groups

TEST Lens

Description:

Eligible subjects that are at least 18 years old, who have been recently fitted (within the last 2 months) with the ACUVUE® OASYS with Transitions™ will be asked to complete follow-up assessments performed online at approximately 2-weeks, 4-months, and 12-months following Visit 1.

Treatment:

Device: ACUVUE® OASYS with Transitions™

CONTROL Lens

Description:

Eligible subjects that are at least 18 years old, who have been recently fitted (within the last 2 months) with spherical non-photochromic reusable marketed silicone hydrogel contact lenses (of any brand) will be asked to complete follow-up assessments performed online at approximately 2-weeks, 4-months, and 12-months following Visit 1.

Treatment:

Device: Silicone Hydrogel Contact Lens