Dextenza With ILUX for Treatment of MGD

NCT04658927 | Completed Phase 4 FDA Drug

• 1 other identifier: NIJM Study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction; Evaporative Dry Eye

Keywords

dry eye; meibomian gland dysfunction

Outcome Measures

Primary Outcomes (2)

• Change in Meibomian gland score (MGS)

  Change from baseline in meibomian gland scores (expressibility and quality)

  Assessed on week 1, week 4 and week 12.

• Patient satisfaction with treatment

  preference for therapy as measured by COMTOL

  Assessed on week 12

Secondary Outcomes (6)

• Change in Matrix metalloproteinase (MMP) -9

  Assessed on Week 1, 4, 12

• Change in corneal staining

  Assessed on week 1, week 4 and week 12

• Change in tear osmolarity

  Assessed on week 1, week 4 and week 12

• Change in Ocular Surface Disease Index (OSDI) score

  Assessed on week 1, week 4 and week 12

• Change in best corrected visual acuity

  Assessed on week 1, week 4 and week 12

Study Arms (3)

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).

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.

Drug: Prednisone acetate

Group 2: Sham dilation

SHAM COMPARATOR

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

Other: Control

Interventions

Dexamethasone, 0.4mg DRUG

iLUX + dextenza

Also known as: dextenza

Dexamethosone intracanalicular insert

Prednisone acetate DRUG

Prednisolone acetate 1% and iLux

Group 1: Prednisolone actetate 1%

Control OTHER

iLUX alone.

Group 2: Sham dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Warrenville Eyecare: lead

Study Sites (1)

Warrenville EyeCare & LASIK

Warrenville, Illinois, 60555, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Interventions

Dexamethasone; Calcium Dobesilate; Prednisone

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienediols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 9, 2020
• Study Start: January 4, 2021
• Primary Completion: January 11, 2021
• Study Completion: May 30, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)