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Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03431441
Recruitment Status : Completed
First Posted : February 13, 2018
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: JJVC Marketed Contact Lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style
Actual Study Start Date : January 16, 2018
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




Primary Outcome Measures :
  1. LogMAR Objective Vision (High Illumination/High Contrast) [ Time Frame: 5 minutes after lens fitting ]
    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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431441


Locations
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United States, Florida
VRC East
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03431441     History of Changes
Other Study ID Numbers: CR-6180
First Posted: February 13, 2018    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes