Visual AcuityNCT04649606
Dynamic Characterisation of Meibomian Gland Structure
An observational study of Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
This will be a single center pilot study to evaluate appearance of the Meibomian glands. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2020to 22 Jun 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 40 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 must satisfy all of the following criteria to be enrolled in the study:
- Healthy adult males and females, 18-40 years of age (inclusive)
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
- The subject must agree not to participate in other clinical research for the duration of this study
- The subject's optimal spherical equivalent distance refraction must be between +1.00 and -2.00 D in each eye
- The subject's refractive cylinder must be ≤-1.00 DC in each eye
- The subject must score less than 4 points (inclusive) in SPEED questionnaire
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating
- 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
- Have had cataract surgery
- 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
- They have history (more than one week in total) of contact lens wear.
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- Any previous, or planned (during the course of the study) ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- 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
- History of allergy to sodium fluorescein or lissamine green
- 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)
- Meibomian gland atrophy exceeds 25% (inclusive) in either lower or upper eyelid
- The central glands atrophy exceeds 25% (inclusive)
- The number of Meibomian glands yielding liquid secretion (MGYLS) is 6 or less (applicable to Phase II subjects only)
- Use of eye makeup on the days of the study visits
- Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrolment
- Employee or immediate family member of an employee of clinical site (e.g. Investigator, Coordinator, Technician)
Trial locations and contacts
1 site in 1 country.
About this study
This will be a single center pilot study to evaluate appearance of the Meibomian glands.
- Conditions
- Visual Acuity
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 |
|---|---|---|
| Experimental | Eligible subjects will undergo repeated observations 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 - Area
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the area corresponding to individual and aggregated Meibomian glands.
Measured: up to 4-week follow-up
Meibomian Gland Appearance - Mean Reflectivity
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the mean reflectivity of individual and aggregated Meibomian glands
Measured: up to 4-week follow-up
Secondary outcomes (3)
Lipid Layer Thickness (LLT)
LLT will be measured using the LipiView® II instrument on the right eye only.
Measured: up to 4-week follow-up
Non-Invasive Tear Break-Up Time (NIBUT)
NIBUT will be evaluated using the Medmont E300 instrument, with three measurements taken for the right eye only, at least 30 seconds apart and the median recorded.
Measured: up to 4-week follow-up
Tear Film Evaporation Rate
Tear film evaporation rate will be assessed using the Eye-VapoMeter for 3 consecutive open eye measurements followed by 3 consecutive closed eye measurements. The mean for each method will be calculated.
Measured: up to 4-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 posted2 Dec 2020
- Study start19 Oct 2020
- Primary completion22 Jun 2021
- Study completion22 Jun 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649606
- Sponsor's protocol ID
- CR-6369
- Status last verified
- Jul 2021
- First submitted
- 9 Nov 2020
- Last updated
- 19 Jul 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Characterisation of Meibomian Gland Structure
- ClinicalTrials.gov ID
- NCT04649606
- Acronym / sponsor ID
- CR-6369
- Conditions
- Visual Acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 2 Dec 2020 (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 center pilot study to evaluate appearance of the Meibomian glands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | –Eligible subjects will undergo repeated observations to evaluate the Meibomian gland appearance |
Who may qualify
- Ages
- 18 to 40 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 (8 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Key exclusion criteria (16 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 - Area
Time frame: up to 4-week follow-up
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the area corresponding to individual and aggregated Meibomian glands.
Meibomian Gland Appearance - Mean Reflectivity
Time frame: up to 4-week follow-up
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the mean reflectivity of individual and aggregated Meibomian glands
3 secondary outcomes
Lipid Layer Thickness (LLT)
Time frame: up to 4-week follow-up
Non-Invasive Tear Break-Up Time (NIBUT)
Time frame: up to 4-week follow-up
Tear Film Evaporation Rate
Time frame: up to 4-week follow-up
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 19 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 8 inclusion and 16 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 19 Jul 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 - Area (time frame: up to 4-week follow-up). The study lists 2 primary outcomes in all. 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 19 Jul 2021.