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Assessment of Intracellular Cytokines and Markers in Cells (Phase 3)

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: NCT03896100
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This is a single arm, prospective, bilateral, non-randomized study that will be split into four elements. Element 1 will be an in vitro non-clinical study and described in the laboratory protocol. Elements 2, 3 and 4 will each be a single non-dispensing visit.

Condition or disease
Impression Cytology

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 3)
Actual Study Start Date : March 28, 2019
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 15, 2019

Group/Cohort
Element 2
Four clinical samples will be taken from each eligible subject and used to assess two clinical removal methods and two in vitro removal methods.
Element 3
Four clinical samples will be taken from each eligible subject and used to assess three different storage methods.
Element 4
Four clinical samples will be taken from each eligible subject and used to assess different ocular regions.



Primary Outcome Measures :
  1. Number of Cells [ Time Frame: 1.5 hours duration of assessment time ]
    The frequency count of cells will be summarized within the category.

  2. Types of Cells [ Time Frame: 1.5 hours duration of assessment time ]
    The percentage of types of cells will be summarized within the category.


Biospecimen Retention:   Samples Without DNA
ocular surface cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Eligible subjects aged 18 years and above with normal healthy eyes will be recruited for this work.
Criteria

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. They are of legal age (18 years) and capacity to volunteer.
    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 for the duration of this study.

      Exclusion Criteria:

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

    1. They have had cataract surgery.
    2. They have had corneal refractive surgery.
    3. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
    4. They are pregnant or breast-feeding.
    5. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history or anaphylaxis or severe allergic reactions.
    6. They have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.
    7. They are currently regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
    8. They are using any topical medications such as eye drops or ointments.
    9. They are a current (i.e. within the last three months) contact lens wearer (wearing a lens in one or both eyes).
    10. History of allergic reaction to sodium fluorescein or topical anesthetic.
    11. They have Grade 3 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining (white light evaluation), tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
    12. Any active ocular infection or inflammation.

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): NCT03896100


Locations
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United Kingdom
Eurolens Research - The University of Manchester
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: NCT03896100     History of Changes
Other Study ID Numbers: CR-6315
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 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: No