- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413279
Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46040
- Eye Surgeons of Indiana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lipiflow Only Group
Patients with dry eye disease Lipiflow only
|
To manage patients with dry eye disease secondary to MGD
|
Experimental: Lipiflow + Dextenza Group
Patients with dry eye disease Lipiflow + Dextenza
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in meibomian gland scores (expressibility and quality)
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12
|
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
Time Frame: Assessed at Week 12
|
As measured by COMTOL Survey
|
Assessed at Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in MMP-9
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
As measured by InflammaDry
|
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Mean change in ocular surface staining
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
As measured by sodium fluorescein and lissamine green
|
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Mean change in tear break-up time (TBUT)
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
As measured by TBUT testing
|
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Mean change in tear osmolarity
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
As measured by TearLab
|
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Mean change in DEQ-5
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
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
|
Mean change in Best-corrected Visual Acuity (BCVA)
Time Frame: Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
As measured by ETDRS chart
|
Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Eye Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- The DIERKER Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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