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

NCT ID: NCT03896100

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2019-09-15

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.

Conditions

Impression Cytology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Element 3

Four clinical samples will be taken from each eligible subject and used to assess three different storage methods.

No interventions assigned to this group

Element 4

Four clinical samples will be taken from each eligible subject and used to assess different ocular regions.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurolens Research - The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

CR-6315

Identifier Type: -

Identifier Source: org_study_id