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OpenTrials
Completed

NCT Number: NCT03896100

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eurolens Research - The University of Manchester

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:
  • They are of legal age (18 years) and capacity to volunteer.
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • 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:
  • They have had cataract surgery.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or breast-feeding.
  • They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history or anaphylaxis or severe allergic reactions.
  • They have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.
  • They are currently regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
  • They are using any topical medications such as eye drops or ointments.
  • They are a current (i.e. within the last three months) contact lens wearer (wearing a lens in one or both eyes).
  • History of allergic reaction to sodium fluorescein or topical anesthetic.
  • 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.
  • Any active ocular infection or inflammation.

Treatment and study plan

Primary outcomes

  1. Number of Cells

    Time frame: 1.5 hours duration of assessment time

    The frequency count of cells will be summarized within the category.

  2. Types of Cells

    Time frame: 1.5 hours duration of assessment time

    The percentage of types of cells will be summarized within the category.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2019
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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