Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 4)

NCT ID: NCT04186858

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2020-01-09

Brief Summary

This is a single-visit, non-randomized, bilateral, cross-sectional study. In a pre-screening assessment, potential subjects will be invited to complete a web-based questionnaire that is validated to determine symptomatic vs asymptomatic contact lens wearers. Results of this questionnaire will be used to determine whether subjects are eligible to proceed to Visit 1. During Visit 1, cell samples will be collected from the front surface of the subject's eyes.

Conditions

Impression Cytology

Study Design

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

Study Groups

Symptomatic

Based on the score of the questionnaire, eligible subjects will be placed in the Symptomatic group where cell samples will be collected from the front surface of the subject's eyes.

No interventions assigned to this group

Asymptomatic

Based on the score of the questionnaire, eligible subjects will be placed in the Asymptomatic group where cell samples will be collected from the front surface of the subject's eyes.

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. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form

2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. Be between 18 and 45 years of age (inclusive) at the time of screening

4. They have worn the same brand of soft contact lenses for at least the previous three months.

5. They agree not to participate in other clinical research trials for the duration of this study.

6. In a pre-study screening assessment, they must have a CLDEQ-8 score of 10 or less (asymptomatic group) or 20 or higher (symptomatic group).

7. They possess a wearable pair of distance glasses and agree to bring these to the study visit (if needed for distance vision correction).

8. They can attain a high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses.

9. Their habitual contact lenses fit satisfactorily.

Exclusion Criteria

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

1. Currently pregnant or lactating

2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study

3. They have an ocular disorder which would normally contraindicate contact lens wear.

4. They have had cataract surgery.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.

8. They are regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.

9. They are using any topical medications such as eye drops or ointments.

10. History of allergic reaction to sodium fluorescein or topical anesthetic.

11. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear

12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

13. 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.

14. Any active ocular infection or inflammation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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-6316

Identifier Type: -

Identifier Source: org_study_id