NCT05626478

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nicole Fram M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Conditions

• Corneal Edema
• Corneal Defect
• Anterior Chamber Inflammation
• Ocular Pain
• Corneal Staining
• Visual Outcome
• CME - Cystoid Macular Edema

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	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.
DRUG	Prednisolone Acetate 1% Oph Susp	Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.
DRUG	Prolensa 0.07% Ophthalmic Solution	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2022-11-23
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study