Dextenza With ILUX for Treatment of MGD

Meibomian Gland Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04658927
• Other study ID #: NIJM Study
• Status: Completed
• Phase: Phase 4
• Start date: January 4, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: July 2022
• Source: Warrenville Eyecare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Evaporative Dry Eye
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Drug:
• Dexamethasone, 0.4mg
iLUX + dextenza
• Prednisone acetate
Prednisolone acetate 1% and iLux

Other:
• Control
iLUX alone.

Locations

Country	Name	City	State
United States	Warrenville EyeCare & LASIK	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Warrenville Eyecare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Patient satisfaction with treatment	preference for therapy as measured by COMTOL	Assessed on week 12
Secondary	Change in Matrix metalloproteinase (MMP) -9	Mean change in MMP-9 from baseline as measured by InflammaDry	Assessed on Week 1, 4, 12
Secondary	Change in corneal staining	Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute grading scale	Assessed on week 1, week 4 and week 12
Secondary	Change in tear osmolarity	Mean change in tear osmolarity from baseline as measured by Tear Lab	Assessed on week 1, week 4 and week 12
Secondary	Change in Ocular Surface Disease Index (OSDI) score	Mean change in OSDI from baseline	Assessed on week 1, week 4 and week 12
Secondary	Change in best corrected visual acuity	Mean change in Best-corrected Visual Acuity (BCVA) from baseline as measured by ETDRS chart	Assessed on week 1, week 4 and week 12
Secondary	Physician Ease of Insertion of Dextenza	Physician ease of insertion as measured by a questionnaire	Assessed on day 1