Dextenza With ILUX for Treatment of MGD

Sponsor

Warrenville Eyecare (Other)

Overall Status

Completed

CT.gov ID

NCT04658927

Collaborator

(none)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction Evaporative Dry Eye	Drug: Dexamethasone, 0.4mg Drug: Prednisone acetate Other: Control	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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 upAll 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)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jan 4, 2021

Actual Primary Completion Date :

Jan 11, 2021

Actual Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethosone intracanalicular insert 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).	Drug: Dexamethasone, 0.4mg iLUX + dextenza Other Names: dextenza
Active Comparator: Group 1: Prednisolone actetate 1% 15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days.	Drug: Prednisone acetate Prednisolone acetate 1% and iLux
Sham Comparator: Group 2: Sham dilation 15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye).	Other: Control iLUX alone.

Arm

Intervention/Treatment

Experimental: Dexamethosone intracanalicular insert

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).

Drug: Dexamethasone, 0.4mg

iLUX + dextenza

Other Names:

dextenza

Active Comparator: Group 1: Prednisolone actetate 1%

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

Drug: Prednisone acetate

Prednisolone acetate 1% and iLux

Sham Comparator: Group 2: Sham dilation

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

Other: Control

iLUX alone.

Outcome Measures

Primary Outcome Measures

Change in Meibomian gland score (MGS) [Assessed on week 1, week 4 and week 12.]
Change from baseline in meibomian gland scores (expressibility and quality)
Patient satisfaction with treatment [Assessed on week 12]
preference for therapy as measured by COMTOL

Secondary Outcome Measures

Change in Matrix metalloproteinase (MMP) -9 [Assessed on Week 1, 4, 12]
Mean change in MMP-9 from baseline as measured by InflammaDry
Change in corneal staining [Assessed on week 1, week 4 and week 12]
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 [Assessed on week 1, week 4 and week 12]
Mean change in tear osmolarity from baseline as measured by Tear Lab
Change in Ocular Surface Disease Index (OSDI) score [Assessed on week 1, week 4 and week 12]
Mean change in OSDI from baseline
Change in best corrected visual acuity [Assessed on week 1, week 4 and week 12]
Mean change in Best-corrected Visual Acuity (BCVA) from baseline as measured by ETDRS chart
Physician Ease of Insertion of Dextenza [Assessed on day 1]
Physician ease of insertion as measured by a questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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