Clinical Evaluation of Therapeutic Meibomian Gland Expression
NCT ID: NCT04997135
Last Updated: 2021-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2021-08-15
2021-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Meibography Subjects
Eligible subjects will undergo testing to evaluate the Meibomian gland appearance
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
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
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%.
18 Years
60 Years
ALL
Yes
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Vision Care, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Vision Care, Inc.
Locations
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The University of Manchester
Manchester, , United Kingdom
Countries
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Other Identifiers
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CR-6455
Identifier Type: -
Identifier Source: org_study_id