Dynamic Characterisation of Meibomian Gland Structure

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04649606
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Dynamic Characterisation of Meibomian Gland Structure
• Actual Study Start Date: Oct 19, 2020
• Actual Primary Completion Date: Jun 22, 2021
• Actual Study Completion Date: Jun 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental Eligible subjects will undergo repeated observations to evaluate the Meibomian gland appearance

Outcome Measures

Primary Outcome Measures

1. Meibomian Gland Appearance - Area [up to 4-week follow-up]

   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.

2. Meibomian Gland Appearance - Mean Reflectivity [up to 4-week follow-up]

   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

Secondary Outcome Measures

1. Lipid Layer Thickness (LLT) [up to 4-week follow-up]

   LLT will be measured using the LipiView® II instrument on the right eye only.

2. Non-Invasive Tear Break-Up Time (NIBUT) [up to 4-week follow-up]

   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.

3. Tear Film Evaporation Rate [up to 4-week follow-up]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Manchester	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT04649606
• Other Study ID Numbers: CR-6369
• First Posted: Dec 2, 2020
• Last Update Posted: Jul 19, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 19, 2021