Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

Visual Acuity Clinical Trial

Official title:

Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431441
• Other study ID #: CR-6180
• Status: Completed
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: February 14, 2018

Study information

• Verified date: February 2019
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 14, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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).

Related Conditions & MeSH terms

• Visual Acuity

Intervention

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.

Locations

Country	Name	City	State
United States	VRC East	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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