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Comparison of Two Silicone Hydrogel Multifocal Contact Lenses

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: NCT04093258
Recruitment Status : Active, not recruiting
First Posted : September 18, 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, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: Dailies Total 1® Multifocal Contact Lenses Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Two Silicone Hydrogel Multifocal Contact Lenses
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Test/Control
Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting.
Device: Dailies Total 1® Multifocal Contact Lenses
TEST

Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®
CONTROL

Experimental: Control/Test
Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting.
Device: Dailies Total 1® Multifocal Contact Lenses
TEST

Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®
CONTROL




Primary Outcome Measures :
  1. Lens Centration [ Time Frame: up to 8 to12-day follow-up ]
    The position of the lens is observed with the subject's eyes in the primary gaze position. Lens centration relative to the cornea is rated as, Centered (Optimal), Slightly decentered, or Substantially decentered.

  2. Lens Movement [ Time Frame: up to 8 to 12-day follow-up ]
    The vertical movement of the contact lens shall be observed in the subject while remaining in primary gaze, upward, and then when the study lens is gently pushed upward. The movement will be graded as Excessive, Unacceptable Movement; Moderate, but Acceptable Movement; Optimal Movement; Minimal but Acceptable Movement; and Insufficient, Unacceptable Movement


Secondary Outcome Measures :
  1. Subjective Lens Handling [ Time Frame: up to 8 to 12-day follow-up ]
    CLUE Handling 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 (inclusive).
    4. The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D or -1.25 D to -4.00 D in each eye.
    5. The subject's refractive cylinder must be ≤0.75 D in each eye.
    6. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
    7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
    8. Subjects must own a wearable pair of spectacles if required for their distance vision.
    9. The subject must be an adapted 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).
    10. The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

      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 ocular or systemic allergies that may interfere with contact lens wear.
    3. 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, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
    4. 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.
    5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
    6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, cataract surgery, retinal surgery, etc.).
    7. A history of amblyopia, strabismus or binocular vision abnormality.
    8. Any current ocular infection or inflammation.
    9. Any current ocular abnormality that may interfere with contact lens wear.
    10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.
    11. Use of any ocular medication, with the exception of rewetting drops.
    12. History of herpetic keratitis.
    13. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
    14. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    15. Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® multipurpose care solution, sodium fluorescein or single-use preservative free rewetting drop solution.

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): NCT04093258


Locations
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United States, Georgia
Visual Eyes
Roswell, Georgia, United States, 30076
United States, Ohio
ProCare Vision Centers
Granville, Ohio, United States, 43023
United States, Tennessee
Optometry Group, LLC
Memphis, Tennessee, United States, 38111
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT04093258     History of Changes
Other Study ID Numbers: CR-6344
First Posted: September 18, 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