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

NCT ID: NCT04413279

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-07-01

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 LipiFlow Thermal Pulsation.

Detailed 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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lipiflow Only Group

Patients with dry eye disease Lipiflow only

Group Type: ACTIVE_COMPARATOR

LipiFlow Thermal Pulsation

Intervention Type: PROCEDURE

To manage patients with dry eye disease secondary to MGD

Lipiflow + Dextenza Group

Patients with dry eye disease Lipiflow + Dextenza

Group Type: EXPERIMENTAL

Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

Intervention Type: 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

Interventions

LipiFlow Thermal Pulsation

To manage patients with dry eye disease secondary to MGD

Intervention Type: PROCEDURE

Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

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

Intervention Type: DRUG

Other Intervention Names

Dextenza

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: collaborator

Eye Surgeons of Indiana

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damon Dierker, OD, FAAO

Role: PRINCIPAL_INVESTIGATOR

Eye Surgeons of Indiana

Locations

Eye Surgeons of Indiana

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

The DIERKER Study

Identifier Type: -

Identifier Source: org_study_id