Clinical trial NCT04997135: Clinical Evaluation of Therapeutic Meibomian Gland Expression
Official title: Clinical Evaluation of Therapeutic Meibomian Gland Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Meibomian Gland
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria

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


Eligibility criteria: 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%.

Primary outcomes:
measure: Meibomian Gland Appearance
timeFrame: up to 2-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: