Meibomian Gland DysfunctionPhase 4NCT04658927
Dextenza With ILUX for Treatment of MGD
A Phase 4 study testing Dexamethasone, 0.4mg and Prednisone acetate in people with Meibomian Gland Dysfunction and Evaporative Dry Eye, run by Warrenville Eyecare at 1 site in United States.
Trial summary
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing iLUX MGD Treatment System. 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?
- Dexamethasone, 0.4mg and Prednisone acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 30 May 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- 18 years of age or older
- Evaporative DED with MGD and clinically significant inflammation
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Who cannot join
- A patient who meets any of the following criteria will be excluded from the study:
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Altered nasolacrimal flow of either acquired, induced, or congenital origin
Show all 9Show fewer
- Hypersensitivity to dexamethasone
- Patient being treated with either topical, oral, or intravenous steroids
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Warrenville EyeCare & LASIK
Warrenville, Illinois, 60555
About this study
Official title: Intracanalicular Dexamethasone Used in Conjunction With ILUX for the Treatment of Meibomian Gland Dysfunction (MGD) in Patients With Evaporative Dry Eye and Evidence of Clinically Significant Inflammation.
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing iLUX MGD Treatment System.
Read the detailed description
This prospective study will use a fellow-eye design for 30 participants, (2 groups of 15) equating to 60 eyes. All eyes will receive bilateral iLUX MGD Treatment System. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye). In group 1, the other eye will be assigned to receive prednisolone acetate 1% on a 4,3,2,1 month taper schedule (active comparator). In group 2, the other eye will receive punctal "sham" dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 30 eyes receiving DEXTENZA® insertion. The control group will consist of 15 eyes receiving prednisolone acetate 1% and 15 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.
- Conditions
- Meibomian Gland Dysfunction, Evaporative Dry Eye
- Being tested
- Dexamethasone, 0.4mg, Prednisone acetate, Control
- Keywords
- dry eye, meibomian gland dysfunction
- 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.
Dexamethasone, 0.4mgDrug
Also called dextenza
iLUX + dextenza
Prednisone acetateDrug
Prednisolone acetate 1% and iLux
ControlOther
iLUX alone.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethosone intracanalicular insert | Experimental | All 30 eyes will undergo iLUX MGD Treatment System for the treatment of evaporative DED secondary to MGD. Patients will have their most symptomatic eye selected to receive the dexamethasone intracanalicular insert at the day of the iLUX MGD Treatment System (study eye). Receives: Drug: Dexamethasone, 0.4mg |
| Group 1: Prednisolone actetate 1% | Active comparator | 15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days. Receives: Drug: Prednisone acetate |
| Group 2: Sham dilation | Sham comparator | 15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Meibomian gland score (MGS)
Change from baseline in meibomian gland scores (expressibility and quality)
Measured: Assessed on week 1, week 4 and week 12.
Patient satisfaction with treatment
preference for therapy as measured by COMTOL
Measured: Assessed on week 12
Secondary outcomes (6)
Change in Matrix metalloproteinase (MMP) -9
Mean change in MMP-9 from baseline as measured by InflammaDry
Measured: Assessed on Week 1, 4, 12
Change in corneal staining
Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute grading scale
Measured: Assessed on week 1, week 4 and week 12
Change in tear osmolarity
Mean change in tear osmolarity from baseline as measured by Tear Lab
Measured: Assessed on week 1, week 4 and week 12
Change in Ocular Surface Disease Index (OSDI) score
Mean change in OSDI from baseline
Measured: Assessed on week 1, week 4 and week 12
Change in best corrected visual acuity
Mean change in Best-corrected Visual Acuity (BCVA) from baseline as measured by ETDRS chart
Measured: Assessed on week 1, week 4 and week 12
Physician Ease of Insertion of Dextenza
Physician ease of insertion as measured by a questionnaire
Measured: Assessed on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start4 Jan 2021
- Primary completion11 Jan 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All eyes will undergo iLUX MGD Treatment System for the treatment of evaporative DED secondary to MGD. Patients will have their most symptomatic eye selected to receive the dexamethasone intracanalicular insert at the day of the iLUX MGD Treatment System (study eye). There will be 2 groups: Group 1: fellow eye will receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days (control eye) Group 2: fellow eye will receive punctal "sham" dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Screening Visit Treatment Visit 1 week follow up 1 month follow up 3 month follow up
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warrenville Eyecare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658927
- Sponsor's protocol ID
- NIJM Study
- Status last verified
- Jul 2022
- First submitted
- 18 Nov 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracanalicular Dexamethasone Used in Conjunction With ILUX for the Treatment of Meibomian Gland Dysfunction (MGD) in Patients With Evaporative Dry Eye and Evidence of Clinically Significant Inflammation.
- ClinicalTrials.gov ID
- NCT04658927
- Acronym / sponsor ID
- NIJM Study
- Conditions
- Meibomian Gland Dysfunction, Evaporative Dry Eye
- Keywords
- dry eye, meibomian gland dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Warrenville EyecareUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 9 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.
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing iLUX MGD Treatment System.
Detailed description
This prospective study will use a fellow-eye design for 30 participants, (2 groups of 15) equating to 60 eyes. All eyes will receive bilateral iLUX MGD Treatment System. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye). In group 1, the other eye will be assigned to receive prednisolone acetate 1% on a 4,3,2,1 month taper schedule (active comparator). In group 2, the other eye will receive punctal "sham" dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 30 eyes receiving DEXTENZA® insertion. The control group will consist of 15 eyes receiving prednisolone acetate 1% and 15 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All eyes will undergo iLUX MGD Treatment System for the treatment of evaporative DED secondary to MGD. Patients will have their most symptomatic eye selected to receive the dexamethasone intracanalicular insert at the day of the iLUX MGD Treatment System (study eye). There will be 2 groups: Group 1: fellow eye will receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days (control eye) Group 2: fellow eye will receive punctal "sham" dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Screening Visit Treatment Visit 1 week follow up 1 month follow up 3 month follow up
| Arm | Type | Receives |
|---|---|---|
| Dexamethosone intracanalicular insert | Experimental | Drug: Dexamethasone, 0.4mgAll 30 eyes will undergo iLUX MGD Treatment System for the treatment of evaporative DED secondary to MGD. Patients will have their most symptomatic eye selected to receive the dexamethasone intracanalicular insert at the day of the iLUX MGD Treatment System (study eye). |
| Group 1: Prednisolone actetate 1% | Active comparator | Drug: Prednisone acetate15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days. |
| Group 2: Sham dilation | Sham comparator | Other: Control15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Key exclusion criteria (9 listed)
- A patient who meets any of the following criteria will be excluded from 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone, 0.4mgAlso: dextenzaiLUX + dextenza | Drug | Dexamethosone intracanalicular insert |
| Prednisone acetatePrednisolone acetate 1% and iLux | Drug | Group 1: Prednisolone actetate 1% |
| ControliLUX alone. | Other | Group 2: Sham dilation |
Primary outcome
Change in Meibomian gland score (MGS)
Time frame: Assessed on week 1, week 4 and week 12.
Change from baseline in meibomian gland scores (expressibility and quality)
Patient satisfaction with treatment
Time frame: Assessed on week 12
preference for therapy as measured by COMTOL
6 secondary outcomes
Change in Matrix metalloproteinase (MMP) -9
Time frame: Assessed on Week 1, 4, 12
Change in corneal staining
Time frame: Assessed on week 1, week 4 and week 12
Change in tear osmolarity
Time frame: Assessed on week 1, week 4 and week 12
Change in Ocular Surface Disease Index (OSDI) score
Time frame: Assessed on week 1, week 4 and week 12
Change in best corrected visual acuity
Time frame: Assessed on week 1, week 4 and week 12
Physician Ease of Insertion of Dextenza
Time frame: Assessed on day 1
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 27 Jul 2022.
- 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.
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?
A Phase 4 study testing Dexamethasone, 0.4mg and Prednisone acetate in people with Meibomian Gland Dysfunction and Evaporative Dry Eye, run by Warrenville Eyecare 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 5 inclusion and 9 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 27 Jul 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Meibomian gland score (MGS) (time frame: Assessed on week 1, week 4 and week 12.). 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 27 Jul 2022.