CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Dextenza 0.4Mg Ophthalmic Insert +2 moredrug
Likely dose
Dextenza 0.4Mg Ophthalmic Insertfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05626478
NCT05626478Phase 4Completed
CompareCT.gov

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen

Nicole Fram M.D.·interventional·Posted Nov 23, 2022·Updated Feb 20, 2026

In Brief

A Phase 4 clinical trial evaluating Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp, and 1 other intervention for Corneal Edema and 6 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome, CME - Cystoid Macular Edema
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedNov 23, 2022
Enrollment StartJun 1, 2023
Primary CompletionFeb 5, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.6 years ago

Interventions

Dextenza 0.4Mg Ophthalmic Insertdrug

DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

Prednisolone Acetate 1% Oph Suspdrug

Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.

Prolensa 0.07% Ophthalmic Solutiondrug

Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.