Clinical trial NCT04649606: Dynamic Characterisation of Meibomian Gland Structure
Official title: Dynamic Characterisation of Meibomian Gland Structure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
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 center pilot study to evaluate appearance of the Meibomian glands.


Eligibility criteria: 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)

Primary outcomes:
measure: Meibomian Gland Appearance - Area
timeFrame: up to 4-week follow-up
measure: Meibomian Gland Appearance - Mean Reflectivity
timeFrame: up to 4-week follow-up
Secondary outcomes:
measure: Lipid Layer Thickness (LLT)
timeFrame: up to 4-week follow-up
measure: Non-Invasive Tear Break-Up Time (NIBUT)
timeFrame: up to 4-week follow-up
measure: Tear Film Evaporation Rate
timeFrame: up to 4-week follow-up
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
References: