CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Dexamethasone ophthalmic insert 0.4 mg +1 moredrug
Likely dose
Dexamethasone ophthalmic insert 0.4 mgfrom 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/NCT04380857
NCT04380857Phase 4Completed
CompareCT.gov

Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)

William Wiley, MD·interventional·Posted May 8, 2020·Updated Oct 6, 2023

In Brief

A Phase 4 clinical trial evaluating Dexamethasone ophthalmic insert 0.4 mg and Topical Prednisolone Acetate Ophthalmic Drops for Post Procedural Infection. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Procedural Infection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMay 8, 2020
Enrollment StartJun 18, 2020
Primary CompletionJun 21, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.1 years ago

Interventions

Dexamethasone ophthalmic insert 0.4 mgdrug

intracanalicular dexamethasone insert

Topical Prednisolone Acetate Ophthalmic Dropsdrug

Topical Prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue