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Corticosteroid

Omidria + Dexycu for Cataract Surgery

Phase 4
Waitlist Available
Research Sponsored by Silverstein Eye Centers
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed pre-operatively and 1 month post-operatively
Awards & highlights

Study Summary

This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

Eligible Conditions
  • Cataract Surgery

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed pre-operatively and 1 month post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed pre-operatively and 1 month post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resolution of anterior chamber inflammation
Secondary outcome measures
Resolution of postoperative pain
Other outcome measures
Best corrected visual acuity
Contrast sensitivity testing
Optical Coherence Tomography (OCT)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Omidria + DexycuExperimental Treatment2 Interventions
Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension
Group II: Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mgExperimental Treatment2 Interventions
Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug)
Group III: Omidria + Prednisolone Acetate 1%Active Control2 Interventions
Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Dexamethasone
FDA approved
Phenylephrine
FDA approved

Find a Location

Who is running the clinical trial?

Silverstein Eye CentersLead Sponsor
1 Previous Clinical Trials
57 Total Patients Enrolled
Ocular Therapeutix, Inc.Industry Sponsor
53 Previous Clinical Trials
5,562 Total Patients Enrolled
2 Trials studying Cataract Surgery
35 Patients Enrolled for Cataract Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
2019. "Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04316936.
~3 spots leftby Apr 2025
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