Dynamic Characterisation of Meibomian Gland Structure

Visual Acuity Clinical Trial

Official title:

Dynamic Characterisation of Meibomian Gland Structure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649606
• Other study ID #: CR-6369
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Visual Acuity

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