Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

NCT03431441 | Completed Results FDA Device

• 1 other identifier: CR-6180
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

JJVC Marketed Contact Lens

EXPERIMENTAL

ACUVUE 2 Vivid Style

Device: JJVC Marketed Contact Lens

Interventions

JJVC Marketed Contact Lens DEVICE

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.

JJVC Marketed Contact Lens

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• 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).
• Females between 18 and 39 (inclusive) years of age at the time of screening.
• 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.
• The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
• Have spherical best corrected visual acuity of 20/30 or better in each eye.
• 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.
• The subject must be willing to be photographed and/or video-taped.

You may not qualify if:

• Currently pregnant or lactating
• 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).
• Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion).
• Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
• 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.
• Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
• Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

VRC East

Jacksonville, Florida, 32256, United States

Location

Results Point of Contact

• Title: Meredith Bishop OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care

mbishop4@its.jnj.com

904-443-1396

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to visible print differences, subjects and investigators will be aware of the patterns/variants of the investigational product. However, subjects will be masked to the lens brand to prevent bias during the lens discussions.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: January 16, 2018
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Locations

US (1)