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

Phase 4
Waitlist Available
Led By Damon Dierker, OD, FAAO
Research Sponsored by Eye Surgeons of Indiana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, week 1, week 4 and week 12
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial evaluates the benefit of a dexamethasone insert for evaporative dry eye disease patients with meibomian gland dysfunction and underlying inflammation.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, week 1, week 4 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, week 1, week 4 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in meibomian gland scores (expressibility and quality)
Patient preference for
Secondary study objectives
Mean change in Best-corrected Visual Acuity (BCVA)
Mean change in DEQ-5
Mean change in MMP-9
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lipiflow + Dextenza GroupExperimental Treatment1 Intervention
Patients with dry eye disease Lipiflow + Dextenza
Group II: Lipiflow Only GroupActive Control1 Intervention
Patients with dry eye disease Lipiflow only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation
2020
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Ocular Therapeutix, Inc.Industry Sponsor
54 Previous Clinical Trials
6,382 Total Patients Enrolled
Eye Surgeons of IndianaLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Damon Dierker, OD, FAAOPrincipal InvestigatorEye Surgeons of Indiana
1 Previous Clinical Trials
5 Total Patients Enrolled
~4 spots leftby Dec 2025
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