Clinical trial NCT04186858: Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 4)
Official title: Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 4)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impression Cytology
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects aged 18 years and above with normal healthy eyes will be recruited for this work.

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.


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.

Primary outcomes:
measure: Number of Cells
timeFrame: ~6 hours of contact lens wear time
measure: Types of Cells
timeFrame: ~6 hours of contact lens wear time
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research - The University of Manchester
Study officials:
References: