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

Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 3)

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.

Study Overview

• Status: Completed
• Conditions: Impression Cytology

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • Eurolens Research - The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects aged 18 years and above with normal healthy eyes will be recruited for this work.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cells	The frequency count of cells will be summarized within the category.	1.5 hours duration of assessment time
Types of Cells	The percentage of types of cells will be summarized within the category.	1.5 hours duration of assessment time

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CR-6315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No