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

Nicole Fram M.D.36 enrolled

Overview

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%.

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg insert, when placed within the lower or upper eye lid canaliculus in conjunction with topical prednisolone acetate 1% for the treatment of pain, and inflammation following corneal transplant surgery (PKP, DSEK, DMEK) as compared to topical prednisolone acetate 1%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Dextenza 0.4Mg Ophthalmic InsertDRUG

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.

Prednisolone Acetate 1% Oph SuspDRUG

Prednisolone Acetate 1% is a corticosteroid used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study: * Age 18 years and older * Scheduled corneal transplant surgery: PKP, DSEK, DMEK * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: * Patients under the age of 18. * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * Active infectious systemic disease * Active infectious ocular or extraocular disease * Presence of punctal plug in the study eye * Obstructed nasolacrimal duct in the study eye(s) * Hypersensitivity to dexamethasone or prednisolone eye drops * Patients being treated with immunomodulating agents in the study eye(s) * Patients being treated with immunosuppressants and/or oral steroids * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Locations (1)

Advanced Vision Care

Los Angeles, California, United States

Outcomes

Primary Outcomes

Mean change in pain score

as measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible

Time frame: Assessed on Day 1,7 and 30

Mean change in inflammation (Cell and Flare) scores

as measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1

Time frame: Assessed on Day 1,7 and 30

Secondary Outcomes

Mean change in duration to corneal re-epithelization

as measured by clinical observation of percentage (%); between 0 to 100%; 0 meaning complete re-epithalization and 100% meaning total corneal defect

Time frame: Assessed on Day 1 and 7

Mean change in size of epithelial defect

as measured by diameter (mm) of defect; 0 meaning no defect

Time frame: Assessed on Day 1 and 7

Impact on the practice/medical team of decreasing the drop burden

as measured by a questionnaire

Time frame: Assessed on day 30

Mean change in duration to clearing of corneal edema

as measured by clinical observation; between 0 to 3; 0 meaning clear cornea and 3+ meaning complete obscuration of anterior chamber and iris

Time frame: Assessed on Day 30, 60 and 90

Data from ClinicalTrials.gov

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