Clinical trial NCT03896100: Assessment of Intracellular Cytokines and Markers in Cells (Phase 3)
Official title: Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 3)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impression Cytology
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
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 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.


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.

Primary outcomes:
measure: Number of Cells
timeFrame: 1.5 hours duration of assessment time
measure: Types of Cells
timeFrame: 1.5 hours duration of assessment time
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research - The University of Manchester
Study officials:
References: