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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413279
• Other study ID #: The DIERKER Study
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2022
• Source: Eye Surgeons of Indiana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Procedure:
• LipiFlow Thermal Pulsation
To manage patients with dry eye disease secondary to MGD

Drug:
• 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

Locations

Country	Name	City	State
United States	Eye Surgeons of Indiana	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Eye Surgeons of Indiana	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient preference for	As measured by COMTOL Survey	Assessed at Week 12
Secondary	Mean change in MMP-9	As measured by InflammaDry	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Secondary	Mean change in ocular surface staining	As measured by sodium fluorescein and lissamine green	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Secondary	Mean change in tear break-up time (TBUT)	As measured by TBUT testing	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Secondary	Mean change in tear osmolarity	As measured by TearLab	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Secondary	Mean change in DEQ-5	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.	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Secondary	Mean change in Best-corrected Visual Acuity (BCVA)	As measured by ETDRS chart	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit