Visual AcuityNCT04997135
Clinical Evaluation of Therapeutic Meibomian Gland Expression
An observational study of Visual Acuity and Meibomian Gland, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
This will be a single centre pilot study to evaluate appearance of the Meibomian glands. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity, Meibomian Gland
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2021to 11 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria
Who may be able to join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be between 18 and 60 (inclusive) years of age at the time of screening. Inclusion Criteria at Baseline Evaluation.
- The subject must have visual acuity of 0.2 high contrast logMAR or better in their current correction or unaided in each eye.
- The subject must have at least 10 Meibomian glands yielding liquid secretion (MGYLS) in central lower eyelid region in each eye.
- The subject eyelids must be easy to evert, at the Investigator's discretion.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or breastfeeding.
- 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.
- Have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic (proxymetacaine hydrochloride) or sodium fluorescein.
- Have a history of cardiac disease or hyperthyroidism.
- Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract etc.)
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- Have participated in any ophthalmic clinical trial within 14 days prior to study enrolment.
- Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Have a history of amblyopia or strabismus.
- Have a history of contact lens wear. A trial period (up to one week) in the past is allowed.
- Wear eye makeup on the days of the study visits.
- 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.
- Have any ocular infection.
- Have central lower eyelid Meibomian gland atrophy that exceeds 25%.
Trial locations and contacts
1 site in 1 country.
About this study
This will be a single centre pilot study to evaluate appearance of the Meibomian glands.
- Conditions
- Visual Acuity, Meibomian Gland
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Meibography Subjects | Eligible subjects will undergo testing to evaluate the Meibomian gland appearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Aug 2021
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997135
- Sponsor's protocol ID
- CR-6455
- Status last verified
- Nov 2021
- First submitted
- 4 Aug 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Therapeutic Meibomian Gland Expression
- ClinicalTrials.gov ID
- NCT04997135
- Acronym / sponsor ID
- CR-6455
- Conditions
- Visual Acuity, Meibomian Gland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single centre pilot study to evaluate appearance of the Meibomian glands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meibography Subjects | – | –Eligible subjects will undergo testing to evaluate the Meibomian gland appearance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria
Key inclusion criteria (7 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Key exclusion criteria (14 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Meibomian Gland Appearance
Time frame: up to 2-week follow-up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Acuity and Meibomian Gland, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian Gland Appearance (time frame: up to 2-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.