CompletedNCT04413279ClinicalTrials.gov record

Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease

Dry Eye Syndromes

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 4
Age range: Not specified - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 20 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 LipiFlow Thermal Pulsation.

Read the full description

This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy.

After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not randomized
Masking: Single masked

Lipiflow Only Group

Patients with dry eye disease Lipiflow only

Procedure: LipiFlow Thermal Pulsation

Lipiflow + Dextenza Group

Patients with dry eye disease Lipiflow + Dextenza

Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

LipiFlow Thermal Pulsation PROCEDURE

To manage patients with dry eye disease secondary to MGD

Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation DRUG

to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Change From Baseline in Meibomian Gland Scores (Expressibility and Quality)

Time frame: Assessed at Baseline, Week 1, Week 4 and Week 12

Meibomian gland expressibility was graded at the slit lamp using the methodology of the pivotal LipiFlow trial. Fifteen glands of the lower eyelid (5 temporal, 5 central, 5 nasal) were each graded on a 0-3 scale (0 = no secretion; 1 = inspissated/toothpaste-like secretion; 2 = cloudy liquid secretion; 3 = clear liquid secretion). Grades were summed to produce a composite Meibomian Gland Expressibility Score ranging from 0 to 45. Higher scores indicate better meibomian gland function. Values shown are the mean score at each study visit.

Patient Preference

Time frame: Assessed at Week 12

As measured by COMTOL Survey