Clinical Evaluation of Therapeutic Meibomian Gland Expression

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

Study Overview

• Status: Completed
• Conditions: Visual Acuity; Meibomian Gland

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria

Description

Inclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 60 (inclusive) years of age at the time of screening. Inclusion Criteria at Baseline Evaluation.
  4. The subject must have visual acuity of 0.2 high contrast logMAR or better in their current correction or unaided in each eye.
  5. The subject must have at least 10 Meibomian glands yielding liquid secretion (MGYLS) in central lower eyelid region in each eye.

  6. The subject eyelids must be easy to evert, at the Investigator's discretion.

     Exclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or breastfeeding.
  2. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
  3. Have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic (proxymetacaine hydrochloride) or sodium fluorescein.
  4. Have a history of cardiac disease or hyperthyroidism.
  5. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract etc.)
  6. Have participated in any ophthalmic clinical trial within 14 days prior to study enrolment.
  7. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  8. Have a history of amblyopia or strabismus.
  9. Have a history of contact lens wear. A trial period (up to one week) in the past is allowed.
  10. Wear eye makeup on the days of the study visits.
  11. Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema or neovascularization, conjunctival or limbal redness) or any other abnormality which would normally contraindicate participation in the study.
  12. Have any ocular infection.
  13. Have central lower eyelid Meibomian gland atrophy that exceeds 25%.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Meibography Subjects; Eligible subjects will undergo testing to evaluate the Meibomian gland appearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meibomian Gland Appearance	Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates length ratio, width, area, intensity, tortuosity, and contrast	up to 2-week follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CR-6455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No