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Corticosteroid

Dextenza for Cataract

Phase 3
Waitlist Available
Research Sponsored by Ocular Therapeutix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is >5 years of age)
Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening, then day 2 through 28
Awards & highlights

Study Summary

This trial compares the safety of Dextenza to prednisolone acetate suspension for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Eligible Conditions
  • Cataract

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 6 years old, or was under 6 when I first joined the study.
Select...
I am scheduled for cataract surgery, possibly with a lens implant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening, then day 2 through 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening, then day 2 through 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
IOP
Subject FLACC Pain Assessment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DextenzaExperimental Treatment1 Intervention
1 dosing group - 37 eyes treated with Dextenza
Group II: PrednisoloneActive Control1 Intervention
1 dosing group - 32 eyes treated with Prednisolone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dextenza Ophthalmic Insert
2020
Completed Phase 3
~70

Find a Location

Who is running the clinical trial?

Ocular Therapeutix, Inc.Lead Sponsor
53 Previous Clinical Trials
5,512 Total Patients Enrolled
14 Trials studying Cataract
1,906 Patients Enrolled for Cataract

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
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
2020. "A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04539548.
~14 spots leftby Apr 2025
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