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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Cells | The frequency count of cells will be summarized within the category | ~6 hours of contact lens wear time |
| Types of Cells | The percentage of types of cells will be summarized within the category. | ~6 hours of contact lens wear time |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 18 and 45 years of age (inclusive) at the time of screening
They have worn the same brand of soft contact lenses for at least the previous three months.
They agree not to participate in other clinical research trials for the duration of this study.
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).
They possess a wearable pair of distance glasses and agree to bring these to the study visit (if needed for distance vision correction).
They can attain a high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses.
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:
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Eligible subjects aged 18 years and above with normal healthy eyes will be recruited for this work.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research - The University of Manchester | Manchester | United Kingdom |
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Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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ocular surface cells