Clinical trial NCT03431441: Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style
Official title: Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-13
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: LogMAR Objective Vision (High Illumination/High Contrast)
timeFrame: 5 minutes after lens fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: VRC East
state: Florida
Study officials:
References: