Trial | NCT04658927  Report issue

Title

Dextenza With ILUX for Treatment of MGD
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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
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 Started
Jan 04
2021
Primary Completion
Jan 11
2021
Study Completion
May 30
2021
Last Update
Jul 27
2022

Drug Dexamethasone, 0.4mg

iLUX + dextenza

  • Other names: dextenza

Drug Prednisone acetate

Prednisolone acetate 1% and iLux

Other Control

iLUX alone.

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).

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.

Group 2: Sham dilation Sham Comparator

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

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
No Results Posted