CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 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/NCT04396990
NCT04396990Phase 4Completed
CompareCT.gov

A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza 0.4 mg for the Treatment of Post-op. Inflammation and Pain in PRK

Vance Thompson Vision·interventional·Posted May 21, 2020·Updated Jul 30, 2024

In Brief

A Phase 4 clinical trial evaluating Dextenza 0.4Mg Ophthalmic Insert and Topical Prednisolone for Refractive Surgery. Completed, enrolled 20 participants across 1 site.

Detailed Summary

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.

Study Details

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

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMay 21, 2020
Enrollment StartJun 8, 2020
Primary CompletionSep 28, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.1 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 Prednisolonedrug

Standard of care topical drop treatment