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Corticosteroid

Dextenza Arm for Dry Eye Syndrome (ENHANCE Trial)

Phase 4
Waitlist Available
Led By John Passarelli, MD
Research Sponsored by Sight Medical Doctors PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 7 and 30
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 7 and 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 7 and 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Mean change in uncorrected Visual Acuity (VA)
Secondary study objectives
Mean change from baseline in (Central Subfield Thickness) CST
Mean change in corneal staining
Mean change in tear break-up time (TBUT)
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dextenza ArmExperimental Treatment1 Intervention
Group II: Prednisolone Acetate 1%Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Find a Location

Who is running the clinical trial?

Ocular Therapeutix, Inc.Industry Sponsor
54 Previous Clinical Trials
6,372 Total Patients Enrolled
Sight Medical Doctors PLLCLead Sponsor
2 Previous Clinical Trials
30 Total Patients Enrolled
John Passarelli, MD4.651 ReviewsPrincipal Investigator - Sight Medical Doctors PLLC
Sight Medical Doctors PLLC
5Patient Review
This post-operative visit went exactly as planned.
~7 spots leftby Nov 2025
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