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

NCT05626478 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-20

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Nicole Fram M.D.

    lead OTHER

Principal Investigators

  • Nicole R Fram, M.D. · Advanced Vision Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-02-05
Completion
2025-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626478 on ClinicalTrials.gov