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Completed

NCT Number: NCT04658927

Dextenza With ILUX for Treatment of MGD

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.

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Key information

Conditions

Meibomian Gland Dysfunction Dry Eye Syndromes Evaporative Dry Eye Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Warrenville EyeCare & LASIK

Warrenville, Illinois, 60555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone, 0.4mg

Drug

iLUX + dextenza

Other names: dextenza

Prednisone acetate

Drug

Prednisolone acetate 1% and iLux

Control

Other

iLUX alone.

Primary outcomes

  1. Change in Meibomian gland score (MGS)

    Time frame: Assessed on week 1, week 4 and week 12.

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

  2. Patient satisfaction with treatment

    Time frame: Assessed on week 12

    preference for therapy as measured by COMTOL

Secondary outcomes

  1. Change in Matrix metalloproteinase (MMP) -9

    Time frame: Assessed on Week 1, 4, 12

    Mean change in MMP-9 from baseline as measured by InflammaDry

  2. Change in corneal staining

    Time frame: Assessed on week 1, week 4 and week 12

    Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute grading scale

  3. Change in tear osmolarity

    Time frame: Assessed on week 1, week 4 and week 12

    Mean change in tear osmolarity from baseline as measured by Tear Lab

  4. Change in Ocular Surface Disease Index (OSDI) score

    Time frame: Assessed on week 1, week 4 and week 12

    Mean change in OSDI from baseline

  5. Change in best corrected visual acuity

    Time frame: Assessed on week 1, week 4 and week 12

    Mean change in Best-corrected Visual Acuity (BCVA) from baseline as measured by ETDRS chart

  6. Physician Ease of Insertion of Dextenza

    Time frame: Assessed on day 1

    Physician ease of insertion as measured by a questionnaire

Sponsors and collaborators

Lead sponsor

Warrenville Eyecare

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2020
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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