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

NCT04413279 | Completed Phase 4 FDA Drug

• 1 other identifier: The DIERKER Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

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

  As measured on a grading scale 1 to 4 and graded by the physician

  Assessed at Baseline, Week 1, Week 4 and Week 12

• Patient preference for

  As measured by COMTOL Survey

  Assessed at Week 12

Secondary Outcomes (6)

• Mean change in MMP-9

  Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

• Mean change in ocular surface staining

  Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

• Mean change in tear break-up time (TBUT)

  Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

• Mean change in tear osmolarity

  Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

• Mean change in DEQ-5

  Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Study Arms (2)

Lipiflow Only Group

ACTIVE COMPARATOR

Patients with dry eye disease Lipiflow only

Procedure: LipiFlow Thermal Pulsation

Lipiflow + Dextenza Group

EXPERIMENTAL

Patients with dry eye disease Lipiflow + Dextenza

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

Interventions

LipiFlow Thermal Pulsation PROCEDURE

To manage patients with dry eye disease secondary to MGD

Lipiflow Only Group

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

Also known as: Dextenza

Lipiflow + Dextenza Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye Surgeons of Indiana: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Eye Surgeons of Indiana

Indianapolis, Indiana, 46040, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Damon Dierker, OD, FAAO

  Eye Surgeons of Indiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

US (1)