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Characterizing Successful Myopic Multifocal Contact Lens Wearers

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: NCT04178772
Recruitment Status : Suspended (To ensure the safety of participants during the COVID-19 pandemic, this clinical trial is suspended until further notice)
First Posted : November 26, 2019
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This will be a prospective, single group, single-arm, and bilateral dispensing study. Subjects will be assigned to a single study lens type to be worn bilaterally in daily wear, and daily disposable modality, for at least 6 hours per day every day for approximately 12 weeks.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Characterizing Successful Myopic Multifocal Contact Lens Wearers
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: JJVC Marketed Contact Lens
Eligible subjects that have no experience with soft multifocal lenses for more than 2 years will be assigned to a single study lens type worn in both eyes daily for at least 6 hours per day, everyday for approximately 12 weeks.
Device: Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens
JJVC Marketed Contact Lens




Primary Outcome Measures :
  1. Likely to be Successful Group [ Time Frame: up to 12- week follow-up ]
    The successful lens wear will be converted to a binary response where 1 = successful lens wear, and 0 = unsuccessful lens wear.

  2. Quest Questionnaire Classification [ Time Frame: at Baseline ]
    Subject will answer a series of questions including Contact Lens Wear History, Occupation Hobbies, Visual Demands, Contact lens Success, Reasons for Success / Failure.


Secondary Outcome Measures :
  1. Auto-refraction & keratometry (Autorefractor) [ Time Frame: at Baseline ]
    Subjects will have their right eye and left eye measured in diopters (0.125 steps).

  2. Refraction including reading addition (Phoropter) [ Time Frame: at Baseline ]
    The near reading addition will be determined using the binocular crossed cylinder technique at 40 cm followed by optimization in a trial frame. The measurement will be recorded in Diopters.

  3. LogMAR (Logarithm of Minimal Angle of resolution) Visual Acuity: monocular & binocular - distance (4m) [ Time Frame: up to 12-week follow-up ]
    Subjects will have their visual acuity tested on their right eye (occluding the left eye), the left eye (occluding the right eye), and both eyes together from a distance of 4m using logMAR visual acuity charts.

  4. LogMAR (Logarithm of Minimal Angle of resolution) Visual Acuity: monocular & binocular - near (40 cm) [ Time Frame: up to 12-week follow-up ]
    Subjects will have their visual acuity tested on their right eye (occluding the left eye), the left eye (occluding the right eye), and both eyes together from a distance of 40 cm using logMAR visual acuity charts.

  5. LogMAR (Logarithm of Minimal Angle of resolution) Visual Acuity: monocular & binocular - intermediate (1 m) [ Time Frame: up to 12-week follow-up ]
    Subjects will have their visual acuity tested on their right eye (occluding the left eye), the left eye (occluding the right eye), and both eyes together from a distance of 1m using logMAR visual acuity charts.

  6. Distance (4m) Fixation Disparity (with refraction) [ Time Frame: up to 12-week follow-up ]
    Subjects will be tested to measure horizontal amount of prism in vision. Fixation disparity will be recorded from 1m distance and will be recorded in Diopters

  7. Near (40cm) Fixation Disparity (with refraction) [ Time Frame: up to 12-week follow-up ]
    Subjects will be tested to measure horizontal amount of prism in vision. Fixation disparity will be recorded from 40cm distance and will be recorded in Diopter.

  8. Blur tolerance (with refraction): binocular, distance only [ Time Frame: at Baseline ]
    Subjects will be positioned in front of a 1m screen where two tests will be performed to indicate when the image on the screen becomes absolutely intolerable and then when the image is just tolerable. The average of the two thresholds will be the 'objectionable blur threshold' and will be recorded in Diopters.

  9. Stereo-acuity: near (40 cm) [ Time Frame: at Baseline ]
    Subjects wearing Polaroid lenses will view a Randot stereo book at 40 cm and indicate which circle appears to be different from the others. The endpoint of the test is when there are two consecutive incorrect responses. The score is the box in which the last correct response was made. The value is recorded in seconds of arc.

  10. Contrast threshold: OD. OS, and OU distance only: [ Time Frame: up to 12-week follow-up ]
    Subject will read letters from a fixed target, 2.4 m distance, first occluding the left eye, then occluding the right eye, and then both eyes together. The subject will continue to read letters as the illumination contrast is reduced. Once the subject identifies few or 0 letters, the contrast threshold will be measured for each eye and both eyes together.

  11. Pupil size: Photopic; OD & OS, distance [ Time Frame: up to 1-week follow-up ]
    In bright light, the diameter of the subject's pupil will be measured with a pupillometer one at a time, in mm, at a distance of 4m.

  12. Pupil size: Photopic; OD & OS, Intermediate [ Time Frame: up to 1-week follow-up ]
    In bright light, the diameter of the subject's pupil will be measured with a pupillometer one at a time, in mm, at a distance of 1m

  13. Pupil size: Photopic; OD & OS, near [ Time Frame: up to 1-week follow-up ]
    In bright light, the diameter of the subject's pupil will be measured with a pupillometer one at a time, in mm, at a distance of 40cm.

  14. Pupil size: Scotopic; OD & OS, distance [ Time Frame: up to 1-week follow-up ]
    In dim light, the diameter of the subject's pupil will be measured with a pupillometer one at a time, in mm, at a distance of 4m

  15. Pupil size: Scotopic; OD & OS, Intermediate [ Time Frame: up to 1-week follow-up ]
    In dim light, the diameter of the subject's pupil will be measured with a pupillometer one at a time, in mm, at a distance of 1m

  16. Pupil size: Scotopic; OD & OS, near [ Time Frame: up to 1-week follow-up ]
    In dim light, the diameter of the subject's pupil will be measured with a pupillometer one at a time, in mm, at a distance of 40cm

  17. Non-invasive tear break-up time (NITBUT): OD & OS (Placido disc): [ Time Frame: at Baseline ]
    NITBUT will be measured and recorded with Placido disc topographer projecting onto pre-lens tear film for each eye. 3 separate measurements will be collected and a mean of the three measurements will be recorded

  18. Objective accommodation with distance refraction (WAM 5500: 4 m, 1 m, and 40 cm target) OD & OS [ Time Frame: up to 12-week follow-up ]
    Objective accommodation will be recorded using WAM 5500 refractometer for 4m, 1m, and 40cm targets with the contact lenses in each eye. The average for each distance measurement for each eye will be recorded.

  19. Spherical aberration OD & OS [ Time Frame: up to 12-week follow-up ]
    Spherical aberrations will be measured using the Complete Ophthalmic Analysis System (COAS), 2 seconds after blink for each eye at distance target Coma (Comatic Abberation)over the Contact lenses. The aberrometer will measure the distortion in microns.

  20. COAS (wavefront measurements), 2 secs after blink, OD & OS @ distance target: [ Time Frame: up to 12-week follow-up ]
    igher order aberrations will be measured with a wavefront aberrometer that measures the distortion of a light wave as it is altered by passing through the optics of the eye. The aberrometer will measure the distortion in microns from a 4m distance for each eye.

  21. Coma(Comatic Abberations) [ Time Frame: up to 12-week follow-up ]
    Comatic aberrations will be measured with a wavefront aberrometer that measures the distortion of a light wave as it is altered by passing through the optics of the eye. The aberrometer will measure the distortion in microns at a 4m distance for each eye.

  22. Other higher order aberrations [ Time Frame: up to 12-week follow-up ]
    Higher order aberrations will be measured with a wavefront aberrometer that measures the distortion of a light wave as it is altered by passing through the optics of the eye. The aberrometer will measure the distortion in microns at a 4m distance for each eye.

  23. Lens centration OD & OS [ Time Frame: at Baseline ]
    Corneal topography will be performed to estimate the contact lens centration on each eye. The lens centration will be measured from the center of the placido disk reflections to the center of the contact lens in mm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 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 participant 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. Is at least 40 years of age (inclusive) at the time of screening and has full legal capacity to volunteer.
    4. Had a self-reported eye examination in the last two years.
    5. The subject must either already be wearing a presbyopic correction (e.g., reading spectacles over contact lenses, or multifocal spectacles, etc.) or respond positively to at least one symptom on the 'Presbyopic Symptoms Questionnaire".
    6. Can achieve best corrected distance monocular visual acuity of at least +0.20 logMAR and binocular visual acuity of at least +0.10 logMAR with refraction.
    7. Have a refractive cylinder of ≤1.00 D in each eye.
    8. Has corrected best sphere equivalent distance refraction in the range -1.25 D of -3.75 D in each eye.
    9. Have a reading ADD power in the range of +0.75 D to +1.75 D (inclusive) in each eye.
    10. Have a wearable pair of spectacles (at the discretion of the investigator) to wear when they cannot wear the study lenses.

      Exclusion Criteria:

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

    1. Participation in any contact lens or lens care clinical trial within 1 week prior to study enrollment.
    2. Employee or immediate family member of an employee of the Centre for Ocular Research & Education listed on the study Delegation Log (e.g., Investigator, Coordinator, Technician).
    3. Is currently pregnant or lactating, by self-report, or planning a pregnancy at the time of enrollment.
    4. Has any known active ocular disease and/or allergies, ocular infections or other abnormalities that are known to interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or corneal distortion.
    5. Is using any topical ocular medications other than lubricating eye drops.
    6. Known to have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
    7. Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
    8. Had a diagnosis of a condition known to affect ocular prescription or ocular surface or tear film e.g., rheumatoid arthritis, diabetes.
    9. Had a change within the previous 3 months to the dosage of a systemic medication known to affect ocular prescription or ocular surface or tear film (e.g., steroids) that in the opinion of the investigator may affect a study outcome variable.
    10. Has undergone cataract or refractive error surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or has any planned (during the study) major surgery (e.g. hip replacement), or any planned ocular surgery (e.g. cataract or refractive error surgery).
    11. Is a current rigid contact lens wearer, or is wearing contact lenses on extended wear basis, or has a history of extended wear in the past 6 months.
    12. Has worn soft MF CLs in the past 2 years or is a habitual wearer of monovision CLs.
    13. Has a constant unilateral strabismus at both far and near distances, or has anisometropia >2 D between both eyes, or has amblyopia.
    14. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study (Refresh Plus® rewetting drop solution, Sodium Fluorescein or Alcon Clear Care Cleaning System).
    15. Has any Grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the biomicroscopy classification scale, 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 (at the discretion of the investigator).

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): NCT04178772


Locations
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Canada, Ontario
Centre for Ocular Research and Education, University of Waterloo
Waterloo, Ontario, Canada
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT04178772    
Other Study ID Numbers: CR-5945
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
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
Product Manufactured in and Exported from the U.S.: Yes