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This will be a single centre pilot study to evaluate appearance of the Meibomian glands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meibography Subjects | Eligible subjects will undergo testing to evaluate the Meibomian gland appearance |
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| Measure | Description | Time Frame |
|---|---|---|
| Meibomian Gland Appearance | Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates length ratio, width, area, intensity, tortuosity, and contrast | up to 2-week follow-up |
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Inclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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 60 (inclusive) years of age at the time of screening. Inclusion Criteria at Baseline Evaluation.
The subject must have visual acuity of 0.2 high contrast logMAR or better in their current correction or unaided in each eye.
The subject must have at least 10 Meibomian glands yielding liquid secretion (MGYLS) in central lower eyelid region in each eye.
The subject eyelids must be easy to evert, at the Investigator's discretion.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester | Manchester | M13 9PL | United Kingdom |
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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