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

Impression Cytology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896100
• Other study ID #: CR-6315
• Status: Completed
• Start date: March 28, 2019
• Est. completion date: September 15, 2019

Study information

• Verified date: October 2019
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Impression Cytology

Locations

Country	Name	City	State
United Kingdom	Eurolens Research - The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cells	The frequency count of cells will be summarized within the category.	1.5 hours duration of assessment time
Primary	Types of Cells	The percentage of types of cells will be summarized within the category.	1.5 hours duration of assessment time