CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Dextenza 0.4Mg Ophthalmic Insert +1 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/NCT05023304
NCT05023304Phase 4Completed
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In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Vance Thompson Vision·interventional·Posted Aug 26, 2021·Updated Aug 17, 2025

In Brief

A Phase 4 clinical trial evaluating Dextenza 0.4Mg Ophthalmic Insert and Topical prednisolone acetate for Cataract. Completed, enrolled 30 participants across 1 site.

Detailed Summary

To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesUnited States
CollaboratorsOcular Therapeutix, Inc.

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedAug 26, 2021
Enrollment StartAug 23, 2021
Primary CompletionJul 27, 2022
Study CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.9 years ago

Interventions

Dextenza 0.4Mg Ophthalmic Insertdrug

The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.

Topical prednisolone acetatedrug

Standard of care topical drop regimen with four week taper