Sponsor study identifier
observational
25
1 country
1
Study Start
October 19, 2020
Actual (reported)Primary Completion
June 22, 2021
Actual (reported)Study Completion
June 22, 2021
Actual (reported)This will be a single center pilot study to evaluate appearance of the Meibomian glands.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 22, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2020
Actual (reported)November 9, 2020
Actual (reported)December 2, 2020
Actual (reported)June 22, 2021
Actual (reported)June 22, 2021
Actual (reported)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
Lipid Layer Thickness (LLT)
up to 4-week follow-up
Non-Invasive Tear Break-Up Time (NIBUT)
up to 4-week follow-up
Tear Film Evaporation Rate
up to 4-week follow-up
Eligible subjects will undergo repeated observations to evaluate the Meibomian gland appearance
Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria
The University of Manchester
Manchester, M13 9PL, United Kingdom
25 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2020
First Posted
December 2, 2020
Study Start
October 19, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 22, 2021
Actual (reported)Study Completion
June 22, 2021
Actual (reported)Last Updated
July 19, 2021
Record last verified: 2021-07
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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Source: ClinicalTrials.gov.
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