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

Johnson & Johnson Vision Care, Inc.1 site in 1 country12 target enrollmentMarch 28, 2019

ConditionsImpression Cytology

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Impression Cytology
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Number of Cells
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 28, 2019

End Date

September 15, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•They are of legal age (18 years) and capacity to volunteer.
•They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
•They are willing and able to follow the protocol.
•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:
•They have had cataract surgery.
•They have had corneal refractive surgery.
•They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
•They are pregnant or breast-feeding.
•They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history or anaphylaxis or severe allergic reactions.
•They have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.
•They are currently regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
•They are using any topical medications such as eye drops or ointments.
•They are a current (i.e. within the last three months) contact lens wearer (wearing a lens in one or both eyes).