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Dextenza With ILUX for Treatment of MGD

Primary Purpose

Meibomian Gland Dysfunction, Evaporative Dry Eye

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone, 0.4mg
Prednisone acetate
Control
Sponsored by
Warrenville Eyecare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring dry eye, meibomian gland dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • 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

Sites / Locations

  • Warrenville EyeCare & LASIK

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Dexamethosone intracanalicular insert

Group 1: Prednisolone actetate 1%

Group 2: Sham dilation

Arm Description

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).

15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days.

15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye).

Outcomes

Primary Outcome Measures

Change in Meibomian gland score (MGS)
Change from baseline in meibomian gland scores (expressibility and quality)
Patient satisfaction with treatment
preference for therapy as measured by COMTOL

Secondary Outcome Measures

Change in Matrix metalloproteinase (MMP) -9
Mean change in MMP-9 from baseline as measured by InflammaDry
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
Change in tear osmolarity
Mean change in tear osmolarity from baseline as measured by Tear Lab
Change in Ocular Surface Disease Index (OSDI) score
Mean change in OSDI from baseline
Change in best corrected visual acuity
Mean change in Best-corrected Visual Acuity (BCVA) from baseline as measured by ETDRS chart
Physician Ease of Insertion of Dextenza
Physician ease of insertion as measured by a questionnaire

Full Information

First Posted
November 18, 2020
Last Updated
July 26, 2022
Sponsor
Warrenville Eyecare
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1. Study Identification

Unique Protocol Identification Number
NCT04658927
Brief Title
Dextenza With ILUX for Treatment of MGD
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warrenville Eyecare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Evaporative Dry Eye
Keywords
dry eye, meibomian gland dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethosone intracanalicular insert
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 1: Prednisolone actetate 1%
Arm Type
Active Comparator
Arm Description
15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days.
Arm Title
Group 2: Sham dilation
Arm Type
Sham Comparator
Arm Description
15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone, 0.4mg
Other Intervention Name(s)
dextenza
Intervention Description
iLUX + dextenza
Intervention Type
Drug
Intervention Name(s)
Prednisone acetate
Intervention Description
Prednisolone acetate 1% and iLux
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
iLUX alone.
Primary Outcome Measure Information:
Title
Change in Meibomian gland score (MGS)
Description
Change from baseline in meibomian gland scores (expressibility and quality)
Time Frame
Assessed on week 1, week 4 and week 12.
Title
Patient satisfaction with treatment
Description
preference for therapy as measured by COMTOL
Time Frame
Assessed on week 12
Secondary Outcome Measure Information:
Title
Change in Matrix metalloproteinase (MMP) -9
Description
Mean change in MMP-9 from baseline as measured by InflammaDry
Time Frame
Assessed on Week 1, 4, 12
Title
Change in corneal staining
Description
Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute grading scale
Time Frame
Assessed on week 1, week 4 and week 12
Title
Change in tear osmolarity
Description
Mean change in tear osmolarity from baseline as measured by Tear Lab
Time Frame
Assessed on week 1, week 4 and week 12
Title
Change in Ocular Surface Disease Index (OSDI) score
Description
Mean change in OSDI from baseline
Time Frame
Assessed on week 1, week 4 and week 12
Title
Change in best corrected visual acuity
Description
Mean change in Best-corrected Visual Acuity (BCVA) from baseline as measured by ETDRS chart
Time Frame
Assessed on week 1, week 4 and week 12
Title
Physician Ease of Insertion of Dextenza
Description
Physician ease of insertion as measured by a questionnaire
Time Frame
Assessed on day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
Warrenville EyeCare & LASIK
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dextenza With ILUX for Treatment of MGD

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