CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Dextenza 0.4Mg Ophthalmic Insertdrug
Likely dose
Dextenza 0.4 mg intracanalicular ophthalmic insert, placed intraoperatively following cataract surgeryAI-extracted
Key inclusion· 4
  • ✓Planning to undergo non-complicated cataract extraction with posterior chamber IOL implant in one or both eyes, with or without iStent/Hydrus/Goniotomy
  • ✓Willing and able to comply with clinic visits and study-related procedures
  • ✓Willing and able to sign informed consent form
  • ✓Not pregnant
Key exclusion· 12
  • ✕Currently treated with corticosteroid implant (e.g., Ozurdex)
  • ✕History of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
  • ✕History of complete punctal occlusion in one or both punctum
  • ✕Currently use topical ophthalmic steroid medications

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

Search/NCT05372315
NCT05372315Phase 4Completed
CompareCT.gov

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL).

Iworks Laser and Vision Center·interventional·Posted May 12, 2022·Updated Aug 23, 2023

In Brief

A Phase 4 clinical trial evaluating Dextenza 0.4Mg Ophthalmic Insert for Cataract. Completed, enrolled 80 participants across 1 site.

Detailed Summary

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Study Details

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

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMay 12, 2022
Enrollment StartJun 15, 2022
Primary CompletionOct 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.1 years ago

Interventions

Dextenza 0.4Mg Ophthalmic Insertdrug

(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.