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This will be a single center pilot study to evaluate appearance of the Meibomian glands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Eligible subjects will undergo repeated observations to evaluate the Meibomian gland appearance |
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| Measure | Description | Time Frame |
|---|---|---|
| Meibomian Gland Appearance - Area | Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the area corresponding to individual and aggregated Meibomian glands. | up to 4-week follow-up |
| Meibomian Gland Appearance - Mean Reflectivity | Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the mean reflectivity of individual and aggregated Meibomian glands | up to 4-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Layer Thickness (LLT) | LLT will be measured using the LipiView® II instrument on the right eye only. | up to 4-week follow-up |
| Non-Invasive Tear Break-Up Time (NIBUT) | NIBUT will be evaluated using the Medmont E300 instrument, with three measurements taken for the right eye only, at least 30 seconds apart and the median recorded. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Healthy adult males and females, 18-40 years of age (inclusive)
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
The subject must agree not to participate in other clinical research for the duration of this study
The subject's optimal spherical equivalent distance refraction must be between +1.00 and -2.00 D in each eye
The subject's refractive cylinder must be ≤-1.00 DC in each eye
The subject must score less than 4 points (inclusive) in SPEED questionnaire
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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| 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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| up to 4-week follow-up |
| Tear Film Evaporation Rate | Tear film evaporation rate will be assessed using the Eye-VapoMeter for 3 consecutive open eye measurements followed by 3 consecutive closed eye measurements. The mean for each method will be calculated. | up to 4-week follow-up |