MedTrace Logo

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

NCT04521140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-07-24

No results posted yet for this study

Summary

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.

Conditions

  • Corneal Edema
  • Corneal Defect
  • Corneal Transplant
  • Penetrating KeratoPlasty
  • Anterior Chamber Inflammation
  • Ocular Pain
  • Intraocular Pressure

Interventions

DRUG

Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA is a corticosteroid 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 used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection

Sponsors & Collaborators

  • Nicole Fram M.D.

    lead OTHER

Principal Investigators

  • Nicole Fram, MD · 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
2020-10-16
Primary Completion
2023-01-04
Completion
2023-01-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04521140 on ClinicalTrials.gov