Meibomian Gland DysfunctionNCT04500821
Evaluation of the LipiFlow System With a New Activator
A study testing Activator LFD-2100 in people with Meibomian Gland Dysfunction, run by Johnson & Johnson Surgical Vision, Inc. at 3 sites in United States.
Trial summary
Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Activator LFD-2100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Oct 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be able to participate in this study, subjects must:
- Be at least 22 years old.
- Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
- Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
- Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
- Ability to understand and respond in English.
Who cannot join
- Subject will not be able to be in the study, if the subject:
- Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
- Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
- Is pregnant, or is breast feeding.
- Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Empire Eye and Laser Center
Bakersfield, California, 93309
Texas Eye Research Center
Hurst, Texas, 76054
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the LipiFlow console and from the questionnaire will be used to assess the clinical utilization of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Activator LFD-2100
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activator LFD-2100Device
LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
| Study group | Role | What they receive |
|---|---|---|
| Activator LFD-2100 | Experimental | LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD Receives: Device: Activator LFD-2100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Completion of LipiFlow Treatment With Activator LFD-2100
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
Measured: 1 day after completion of LipiFlow treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start2 Oct 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision Clinical Trials, Study director, Johnson & Johnson Surgical vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500821
- Sponsor's protocol ID
- DRYE-105-ACTS
- Status last verified
- Jan 2022
- First submitted
- 22 Jul 2020
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project 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 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
- ClinicalTrials.gov ID
- NCT04500821
- Acronym / sponsor ID
- DRYE-105-ACTS
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the LipiFlow console and from the questionnaire will be used to assess the clinical utilization of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activator LFD-2100 | Experimental | Device: Activator LFD-2100LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 22 years old.
- Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
- Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
- Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
- Ability to understand and respond in English.
Key exclusion criteria (5 listed)
- Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
- Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
- Is pregnant, or is breast feeding.
- Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activator LFD-2100LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD | Device | Activator LFD-2100 |
Primary outcome
Successful Completion of LipiFlow Treatment With Activator LFD-2100
Time frame: 1 day after completion of LipiFlow treatment
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project 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 Surgical Vision Clinical Trials study director
Johnson & Johnson Surgical vision
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activator LFD-2100 in people with Meibomian Gland Dysfunction, run by Johnson & Johnson Surgical Vision, Inc. at 3 sites in United States.
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 6 inclusion and 5 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Completion of LipiFlow Treatment With Activator LFD-2100 (time frame: 1 day after completion of LipiFlow treatment). 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 24 Jan 2022.