NCT04658927

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Warrenville Eyecare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Dexamethasone, 0.4mg	iLUX + dextenza
DRUG	Prednisone acetate	Prednisolone acetate 1% and iLux
OTHER	Control	iLUX alone.

Timeline

• Start date: 2021-01-04
• Primary completion: 2021-01-11
• Completion: 2021-05-30
• First posted: 2020-12-09
• Last updated: 2022-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study