Dextenza With ILUX for Treatment of MGD

NCT ID: NCT04658927

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2021-05-30

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.

Conditions

Meibomian Gland Dysfunction; Evaporative Dry Eye

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Dexamethasone, 0.4mg

Intervention Type: DRUG

iLUX + dextenza

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.

Group Type: ACTIVE_COMPARATOR

Prednisone acetate

Intervention Type: DRUG

Prednisolone acetate 1% and iLux

Group 2: Sham dilation

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

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

iLUX alone.

Interventions

Dexamethasone, 0.4mg

iLUX + dextenza

Intervention Type: DRUG

Prednisone acetate

Prednisolone acetate 1% and iLux

Intervention Type: DRUG

Control

iLUX alone.

Intervention Type: OTHER

Other Intervention Names

dextenza

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Warrenville Eyecare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Warrenville EyeCare & LASIK

Warrenville, Illinois, United States

Countries

United States

Other Identifiers

NIJM Study

Identifier Type: -

Identifier Source: org_study_id