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Contact Lens Insertion and Removal in a Senior Subject Demographic

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: NCT03597178
Recruitment Status : Completed
First Posted : July 24, 2018
Results First Posted : August 12, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: senofilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Contact Lens Insertion and Removal in a Senior Subject Demographic
Actual Study Start Date : June 29, 2018
Actual Primary Completion Date : July 12, 2018
Actual Study Completion Date : July 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: senofilcon A
Subjects that are of at least 60 years of age and non-habitual contact lens wearers will receive instructions to insert and remove a contact lens from each eye.
Device: senofilcon A
ACUVUE OASYS® 1-DAY with HydraLuxe™ Technology




Primary Outcome Measures :
  1. Overall Success Rate of Insertion and Removal of a Contact Lens [ Time Frame: Lens insertion and Removal, up to 2-Hours ]
    The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
    3. Must be at least 60 years of age at the time of screening.
    4. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
    5. The subject must have best corrected visual acuity (BCVA) of 20/30 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. A habitual and adapted wearer of contact lenses (have worn a contact lens at least one time in the past 5 years).
    2. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
    3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
    4. Any ocular infection.
    5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
    6. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
    7. History of binocular vision abnormality or strabismus.
    8. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
    9. Suspicion of or recent history of alcohol or substance abuse.
    10. History of serious mental illness.
    11. History of seizures.
    12. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
    13. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
    14. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale
    15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate 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): NCT03597178


Locations
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United States, Florida
VRC-East
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Investigators
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Study Director: Brian Pall, OD, MS, FAAO 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: NCT03597178     History of Changes
Other Study ID Numbers: CR-6289
First Posted: July 24, 2018    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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