Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

This will be a single site, non-randomized, dispensing, brand-masked to the subject, bilateral single treatment study. There will be 2 study visits with a 10 to 14-day contact lens wear period between visits.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: JJVC Marketed Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • VRC East

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e., willing to wear only the study lenses and not use habitual lenses during the study).
3. Females between 18 and 39 (inclusive) years of age at the time of screening.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
5. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
6. Have spherical best corrected visual acuity of 20/30 or better in each eye.
7. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report.
8. The subject must be willing to be photographed and/or video-taped.

Exclusion Criteria:

1. Currently pregnant or lactating
2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion).
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion).
4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear.
6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JJVC Marketed Contact Lens; ACUVUE 2 Vivid Style	Device: JJVC Marketed Contact Lens; Female subjects that are habitual contact lens wearers between the ages of 18 to 39 will be dispensed 1 treatment of the JJVC Marketed Contact Lens during the 2-visit study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LogMAR Objective Vision (High Illumination/High Contrast)	Monocular high illuminance high contrast VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.	5 minutes after lens fitting

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): February 14, 2018
• Study Completion (Actual): February 14, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CR-6180

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes