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Ocular Characteristics in Contact Lens and Spectacle Wear

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: NCT03913377
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: Spectacles Device: ACUVUE OASYS®1-Day with HydraLuxe™ Technology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ocular Characteristics in Contact Lens and Spectacle Wear
Actual Study Start Date : April 9, 2019
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Observational
Eligible subjects that are habitual spectacle wearers will use their habitual optical correction and undergo ocular evaluations and questionnaires at the baseline and 1-week visit.
Device: Spectacles
Subjects' own habitual spectacles

Experimental: Interventional
Eligible subjects that are habitual contact lens wearers who own spectacles will be randomized into 1 of 2 sequences (Spectacle/ACUVUE OASYS 1-Day or ACUVUE OASYS 1-Day/Spectacle)
Device: Spectacles
Subjects' own habitual spectacles

Device: ACUVUE OASYS®1-Day with HydraLuxe™ Technology
Test 1




Primary Outcome Measures :
  1. Non-invasive break up time (NIBUT) [ Time Frame: up to 4-week follow-up ]
    Using a corneal topographer, NIBUT will be measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort.

  2. Non-invasive keratography break up time (NIKBUT) [ Time Frame: up to 4-week follow-up ]
    Using a keratography instrument, NIKBUT will be measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort.


Secondary Outcome Measures :
  1. Meibomian Gland Expressibility [ Time Frame: up to 4-week follow-up ]
    Meibomian gland expressiblity is assessed in three regions of the lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region and evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. The total score is calculated as the sum of all grades across the three regions and ranges from 0 to 45.

  2. Conjunctival Staining [ Time Frame: up to 4-week follow-up ]
    Conjunctival staining is graded and recorded by quadrant (Superior, Inferior, Nasal, and Temporal) using the following grading scale: Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate, and Grade 4 = Severe. Average grade can be calculated based on grades of the four quadrants.

  3. Lid Wiper Epitheliopathy [ Time Frame: up to 4-week follow-up ]
    Horizontal lid margin staining and sagittal lid margin staining are graded for each eyelid separately. The horizontal and sagittal grades are then averaged for each eyelid to obtain the upper lid average grade and lower lid average grade. The final grade is the average of the upper and lower lid average grades. Subjects can be classified according to their final grades for each eye. The classification is defined as follows: "None" for final grades of 0, "Mild" for final grades between 0.25 and 1.00, "Moderate" for final grades between 1.25 and 2.00, and "Severe" for final graded between 2.25 and 3.00.



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:   18 Years to 42 Years   (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 will have completed the pre-screening Classification questionnaire.
    2. Subject must have a working cell phone capable of sending and receiving text messages.
    3. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
    4. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    5. Between 18 and 42 (inclusive) years of age at the time of screening
    6. Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week wear time over the last 1 month by self-report OR be a full-time spectacle wearer (7 days/ week) without contact lens wear over the last 6 months.
    7. Subjects must be willing to adhere to spectacle-only refractive correction for approximately 1 week.
    8. Subjects must possess a functional / usable pair of spectacles with which they can achieve 20/20 Snellen visual acuity or better at distance and near, and bring them to the visit
    9. The subject's vertex corrected spherical distance refraction must be in the range (+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye.
    10. The subject's vertex corrected refractive cylinder must be equal or less than -0.75 diopters in each eye.
    11. Contact lens wearers must have spherical best corrected visual acuity of 20/25 or better in each eye.
    12. Snellen visual acuity at distance and near must be within 1 line between subject's own spectacle and the manifest refraction, distance and near, OD & OS.

      Exclusion Criteria:

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

    1. Currently pregnant or lactating, by self-report
    2. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
    3. Any active ocular abnormalities/conditions that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
    4. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
    5. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
    6. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
    7. Habitual spectacle contains an add power, transition or tint.
    8. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
    9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
    10. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician)
    11. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator)
    12. 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.
    13. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale (CTP-2018).
    14. Accommodative/binocular dysfunction, determined by study procedures.

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): NCT03913377


Locations
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United States, Florida
VRC-East
Jacksonville, Florida, United States, 32256
Sabal Eye Care
Longwood, Florida, United States, 32779
United States, New York
Manhattan Vision Associates
New York, New York, United States, 10022
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03913377     History of Changes
Other Study ID Numbers: CR-6332
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 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