Meibomian Gland DysfunctionNCT03055897
Tear Film Innovations iLux Safety Study
A study testing iLux 2020 System in people with Meibomian Gland Dysfunction and Evaporative Dry Eye, run by Tear Film Innovations, Inc. at 1 site in United States.
Trial summary
The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction, Evaporative Dry Eye
- What is being tested?
- iLux 2020 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2016to 18 May 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign written informed consent prior to study participation
Who cannot join
- History of ocular surgery within 1 year
- Active ocular infection
- Ocular surface abnormality; lid surface abnormalities
- Pregnant, nursing or not utilizing adequate birth control measures
- Other protocol-specified exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
TearFilm Innovations Investigative Site
Encinitas, California, 92924
About this study
The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.
Read the detailed description
Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.
- Conditions
- Meibomian Gland Dysfunction, Evaporative Dry Eye
- Being tested
- iLux 2020 System
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLux 2020 SystemDevice
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
| Study group | Role | What they receive |
|---|---|---|
| iLux 2020 System | Experimental | Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual Receives: Device: iLux 2020 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
Post-heating values were obtained by infrared camera for each participant. The cornea, the eyelid, and the surface tissue surrounding the eye were measured. Both eyes contributed to the analysis. No formal hypothesis testing was specified.
Measured: Day 0 immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start3 May 2016
- Primary completion17 May 2016
- Study completion18 May 2016
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tear Film Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. CDMA Project Lead, CDMA Ocular Health, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055897
- Sponsor's protocol ID
- 2020-02
- Status last verified
- Nov 2020
- First submitted
- 10 Feb 2017
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Film Innovations iLux Safety Study
- ClinicalTrials.gov ID
- NCT03055897
- Acronym / sponsor ID
- 2020-02
- Conditions
- Meibomian Gland Dysfunction, Evaporative Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tear Film Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2016 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 18 May 2016 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.
Detailed description
Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iLux 2020 System | Experimental | Device: iLux 2020 SystemMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sign written informed consent prior to study participation
Key exclusion criteria (5 listed)
- History of ocular surgery within 1 year
- Active ocular infection
- Ocular surface abnormality; lid surface abnormalities
- Pregnant, nursing or not utilizing adequate birth control measures
- Other protocol-specified exclusion criteria may apply
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 |
|---|---|---|
| iLux 2020 SystemMedical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands | Device | iLux 2020 System |
Primary outcome
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
Time frame: Day 0 immediately post-treatment
Post-heating values were obtained by infrared camera for each participant. The cornea, the eyelid, and the surface tissue surrounding the eye were measured. Both eyes contributed to the analysis. No formal hypothesis testing was specified.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sr. CDMA Project Lead, CDMA Ocular Health study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLux 2020 System in people with Meibomian Gland Dysfunction and Evaporative Dry Eye, run by Tear Film Innovations, Inc. at 1 site 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 1 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 12 Apr 2023. 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 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 16 Dec 2020). 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?
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment (time frame: Day 0 immediately post-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 12 Apr 2023.