## Protocol Section
### Identification Module
**NCT ID:** NCT04413279

**Brief Title:** Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease

**Official Title:** Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation

#### Organization Study ID Info
**ID:** The DIERKER Study
#### Organization
**Class:** NETWORK
**Full Name:** Eye Surgeons of Indiana
### Status Module
#### Completion Date
**Date:** 2021-07-01

**Type:** ACTUAL

#### Last Update Post Date
**Date:** 2022-04-18

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-08-01

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2020-06-02
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-28
**Study First Submit QC Date:** 2020-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Ocular Therapeutix, Inc.

#### Lead Sponsor

**Class:** NETWORK

**Name:** Eye Surgeons of Indiana

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Dry Eye Syndromes

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with dry eye disease Lipiflow only

**Intervention Names:**

- Procedure: LipiFlow Thermal Pulsation

**Label:** Lipiflow Only Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients with dry eye disease Lipiflow + Dextenza

**Intervention Names:**

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

**Label:** Lipiflow + Dextenza Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lipiflow Only Group

**Description:** To manage patients with dry eye disease secondary to MGD

**Name:** LipiFlow Thermal Pulsation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Lipiflow + Dextenza Group

**Description:** 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

**Name:** Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

**Other Names:**

- Dextenza

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

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

**Time Frame:** Assessed at Baseline, Week 1, Week 4 and Week 12

**Description:** As measured by COMTOL Survey

**Measure:** Patient preference for

**Time Frame:** Assessed at Week 12

#### Secondary Outcomes

**Description:** As measured by InflammaDry

**Measure:** Mean change in MMP-9

**Time Frame:** Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

**Description:** As measured by sodium fluorescein and lissamine green

**Measure:** Mean change in ocular surface staining

**Time Frame:** Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

**Description:** As measured by TBUT testing

**Measure:** Mean change in tear break-up time (TBUT)

**Time Frame:** Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

**Description:** As measured by TearLab

**Measure:** Mean change in tear osmolarity

**Time Frame:** Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

**Description:** As measured by DEQ-5 Questionnaire (Dry Eye Questionnaire. The DEQ-5 is comprised of 5 items: frequency of watery eyes, discomfort, and dryness (0-4 scale) and late day discomfort and dryness intensity (0-5 scale). Higher numbers indicate more severe symptoms.

**Measure:** Mean change in DEQ-5

**Time Frame:** Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

**Description:** As measured by ETDRS chart

**Measure:** Mean change in Best-corrected Visual Acuity (BCVA)

**Time Frame:** Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

### Eligibility Module

**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

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Indianapolis

**Country:** United States

**Facility:** Eye Surgeons of Indiana

**State:** Indiana

**Zip:** 46040

#### Overall Officials

**Official 1:**

**Affiliation:** Eye Surgeons of Indiana

**Name:** Damon Dierker, OD, FAAO

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000007637

- Term: Keratoconjunctivitis

- ID: D000003231

- Term: Conjunctivitis

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000007634

- Term: Keratitis

- ID: D000003316

- Term: Corneal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: HIGH

- As Found: Dry Eye

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: HIGH

- As Found: Dry Eye

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Eye Disease

- ID: M2143

- Name: Meibomian Gland Dysfunction

- Relevance: LOW

- As Found: Unknown

- ID: M10663

- Name: Keratoconjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6455

- Name: Conjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10660

- Name: Keratitis

- Relevance: LOW

- As Found: Unknown

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000007638

- Term: Keratoconjunctivitis Sicca

- ID: D000005128

- Term: Eye Diseases

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M199152

- Name: BB 1101

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2023-10-04

##### Submission Infos

- MCP Release N: 3

- Release Date: 2023-10-04

- Reset Date: 2023-10-27

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
