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Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia

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ClinicalTrials.gov Identifier: NCT04073186
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32 hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in the study lens, optimized if required and worn for approximately 2 weeks. Subjects will then have a washout period of approximately 1 week and be refit in the lenses and be dispensed for an additional 2 weeks of wear.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: ACUVUE® OASYS with Transitions™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia
Actual Study Start Date : August 7, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: ACUVUE® OASYS with Transitions™
Eligible subjects between the ages of 40 to 70 years of age and habitual wearers of soft contact lenses will be fitted with the study lens for two wearing cycles.
Device: ACUVUE® OASYS with Transitions™
JJVC Marketed Contact Lens




Primary Outcome Measures :
  1. Near LogMAR (Logarithm of Minimal Angle of Resolution) Visual Acuity [ Time Frame: up to approximately 2-week follow-ups ]
    Subjects will have their visual acuity tested on both eyes together from a distance of 40cm using logMAR visual acuity charts.

  2. Intermediate LogMAR (Logarithm of Minimal of Resolution) Visual Acuity [ Time Frame: up to approximately 2-week follow-ups ]
    Subjects will have their visual acuity tested on both eyes together from a distance of 64cm using logMAR visual acuity charts.

  3. Distance LogMAR (Logarithm of Minimal Angle of Resolution) Visual Acuity [ Time Frame: up to approximately 2-week follow-ups ]
    Subjects will have their visual acuity tested on both eyes together from a distance of 4m using logMAR visual acuity charts.

  4. CLUE Vision [ Time Frame: up to approximately 2-week follow-ups ]
    CLUE Vision is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Potential subjects must satisfy all 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. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. The subject must be between 40 and 70 years of age at the time of screening.
    4. Subjects must own a wearable pair of spectacles if required for their distance vision.
    5. The subject must be an adapted monovision soft contact lens wearer in both eyes (i.e., worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
    6. The subject's distance spherical equivalent refraction must be in the range of +3.50 D to -4.00 D in each eye.
    7. The subject's refractive cylinder must be ≤1.00 D in each eye.
    8. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
    9. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently Pregnant or lactating.
    2. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
    3. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), systemic steroids.
    4. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, dacryocystorhinostomy, etc.).
    5. Use of any ocular medication, with the exception of rewetting drops.
    6. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
    7. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    8. Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® care cleaning solution, non-preserved rewetting drop solution or sodium fluorescein.
    9. History of herpetic keratitis.
    10. Entropion, ectropion, chalazia, glaucoma, history of recurrent corneal erosions.
    11. A history of amblyopia, strabismus or binocular vision abnormality.
    12. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
    13. Any ocular infection or inflammation.
    14. Any ocular abnormality that may interfere with contact lens wear.
    15. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.

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): NCT04073186


Contacts
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Contact: Thomas R Karkkainen, OD, MS, FAAO 1-800-843-2020 tkarkkai@its.jnj.com

Locations
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United States, Florida
VRC-East Recruiting
Jacksonville, Florida, United States, 32256
United States, Missouri
Advanced Eyecare Recruiting
Raytown, Missouri, United States, 64133
United States, New York
Manhattan Vision Associates Recruiting
New York, New York, United States, 10022
United States, Ohio
Western Reserve Vision Care, Inc. Recruiting
Beachwood, Ohio, United States, 44122
United States, Rhode Island
Dr. David W. Ferris & Associates Recruiting
Warwick, Rhode Island, United States, 02886
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT04073186     History of Changes
Other Study ID Numbers: CR-6349
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
URL: http://yoda.yale.edu

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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
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases