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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04649606
Other study ID # CR-6369
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 19, 2020
Est. completion date June 22, 2021

Study information

Verified date July 2021
Source Johnson & Johnson Vision Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This will be a single center pilot study to evaluate appearance of the Meibomian glands.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 22, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Healthy adult males and females, 18-40 years of age (inclusive) 2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form 3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol 4. The subject must agree not to participate in other clinical research for the duration of this study 5. The subject's optimal spherical equivalent distance refraction must be between +1.00 and -2.00 D in each eye 6. The subject's refractive cylinder must be =-1.00 DC in each eye 7. 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: 1. Currently pregnant or lactating 2. Any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g. hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g. HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study 3. Have had cataract surgery 4. Use of systemic medications (e.g. chronic steroid use) and any current use of ocular medications (e.g. lubricants, artificial tears) that would interfere with participation in the trial, at the Investigator's discretion 5. They have history (more than one week in total) of contact lens wear. 6. Any previous, or planned (during the course of the study) ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.) 7. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, corneal distortion or keratoconus 8. History of allergy to sodium fluorescein or lissamine green 9. Any Grade 1.5 or greater slit lamp findings (e.g. oedema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron Grading Scales or other ocular abnormality including Meibomian gland dysfunction (MGD) or blepharitis (Grade 1.0 or greater) 10. Meibomian gland atrophy exceeds 25% (inclusive) in either lower or upper eyelid 11. The central glands atrophy exceeds 25% (inclusive) 12. The number of Meibomian glands yielding liquid secretion (MGYLS) is 6 or less (applicable to Phase II subjects only) 13. Use of eye makeup on the days of the study visits 14. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrolment 15. Employee or immediate family member of an employee of clinical site (e.g. Investigator, Coordinator, Technician)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom The University of Manchester Manchester

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary Lipid Layer Thickness (LLT) LLT will be measured using the LipiView® II instrument on the right eye only. up to 4-week follow-up
Secondary 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. up to 4-week follow-up
Secondary 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
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