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Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft 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: NCT03871543
Recruitment Status : Suspended (To ensure the safety of participants during the COVID-19 pandemic, this clinical trial is suspended until further notice)
First Posted : March 12, 2019
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing clinical study. In Part 1 (Visits 1-4) all subjects will be Test Lens 1, in Part 2 (Visits 1-4) eligible subjects will be dispensed Test Lens 2 based on their responses to the CLDEQ-8 questionnaire. Subjects scoring between 11 and 19 on the CLDEQ will not continue into Part 2

Condition or disease Intervention/treatment Phase
Visual Acuity Device: AquaComfort Plus Device: Acuvue Oasys 1-Day Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Part 1
All eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1
Device: AquaComfort Plus
Test Lens 1

Part 2
All eligible subjects (based on CLDEQ responses) enrolled into Part 2 will be fit and dispensed with Test Lens 2 and will follow the same procedures as Part 1.
Device: Acuvue Oasys 1-Day
Test Lens 2




Primary Outcome Measures :
  1. Subjective Grade of Lid Margin Staining [ Time Frame: Approximately 14 hours of contact lens wear ]
    Lid margin staining of the upper and lower eyelids will be performed in the left eye (OS) only using lissamine green. The following will be graded subjectively for each eyelid: Horizontal length of staining, Sagittal width of staining, and Average staining grade - this is the average of the horizontal and sagittal grades for each eyelid. A final grade will be calculated which is the average of each eyelid's average staining grade.

  2. Objective Grade of Lid Margin Staining [ Time Frame: Approximately 14 hours of contact lens wear ]
    Lid margin staining of the upper and lower eyelids will be performed in the left eye (OS) only using lissamine green. For the objective image analysis three metrics of staining will be evaluated; (1) Staining Area, (2) Staining Intensity and (3) Staining thickness.

  3. Non-invasive Break-up Time (NIBUT) [ Time Frame: Approximately 14 hours of contact lens wear ]
    NIBUT will be measured in timed seconds using the Medmont topographer for the right eye (OD) only.

  4. Tear Meniscus Height [ Time Frame: Approximately 14 hours of contact lens wear ]
    The lower tear meniscus in the right eye (OD) only will be imaged and measured in mm using optical coherence tomography (OCT).

  5. Tear Film Osmolarity [ Time Frame: Approximately 14 hours of contact lens wear ]
    Tear film osmolarity will be collected and measured in (mOsms/L) in the right eye (OD) only using the Tearlab (Tearlab Corp.)

  6. White Blood Cells [ Time Frame: Approximately 6 hours of contact lens wear ]
    Images, using Confocal Microscopy will be taken in both eyes for both the upper and lower eyelid in the central lid area. These images will be used to determine the mean density of inflammatory white blood cells.


Secondary Outcome Measures :
  1. Beginning Day Comfort [ Time Frame: 5 minutes post lens insertion ]
    Contact lens comfort will be assessed at the beginning of day using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable.

  2. End of Day Comfort [ Time Frame: Approximately 14 hours of contact lens wear ]
    Contact lens comfort will be assessed at the end of day using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable.



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 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Potential subjects must satisfy all of the criteria listed to be enrolled in the study.

    1. They are 18-45 years of age (inclusive).
    2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
    3. They are willing and able to follow the protocol.
    4. They agree not to participate in other clinical research while enrolled on this study.
    5. They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal.
    6. They agree to wear their lenses for at least 12-14 hours per day.
    7. They own a wearable pair of spectacles (by self-report).
    8. They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction).
    9. They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
    10. They have best corrected distance visual acuity of at least 0.20 binocularly

      Exclusion Criteria:

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

    1. They have an ocular disorder which would normally contraindicate contact lens wear.
    2. They have a systemic disorder which would normally contraindicate contact lens wear.
    3. No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses.
    4. They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week).
    5. They have had cataract surgery.
    6. They have had corneal refractive surgery.
    7. They are pregnant or breast-feeding.
    8. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions.
    9. They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician).
    10. They have taken part in any other clinical trial or research within two weeks prior to starting this study.
    11. History of allergy to sodium fluorescein or lissamine green.
    12. They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus.
    13. They any slit lamp findings of Efron Grade 3 or greater (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of < Grade 3 which in the investigator's opinion would 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): NCT03871543


Locations
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United Kingdom
The University of Manchester - Eurolens Research
Manchester, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03871543    
Other Study ID Numbers: CR-6290
First Posted: March 12, 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