Clinical trial

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone Acetate 1% Treating Pain, and inflamMation Following Corneal Transplant Surgery Compared to Topical Prednisolone Acetate 1%.

Name

AVC-002

Description

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%.

Trial arms

Trial start

2020-10-16

Estimated PCD

2023-01-04

Trial end

2023-01-04

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

DMEK with Dextenza (study), DSEK with Dextenza (study), PKP with Dextenza (study)

Other names:

Dexamethasone Ophthalmic Insert

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

Arms:

DMEK with Dextenza (study), DMEK without Dextenza (Controlled), DSEK with Dextenza (study), DSEK without Dextenza (Controlled), PKP with Dextenza (study), PKP without Dextenza (Controlled)

Other names:

Omnipred, Pred Forte

Size

Primary endpoint

Mean change in pain score

Assessed on Day 1,7 and 30

Mean change in inflammation (Cell and Flare) scores

Assessed on Day 1,7 and 30

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In patient who undergo corneal transplant (PKP,DSEK,DMEK), subjects will be randomized to 6 arms and be followed for a period of 3 months.\n\nFirst arm will Receive Dextenza with PKP, Second arm will receive Prednisolone Acetate 1% with PKP, Third arm will Receive Dextenza with DSEK, Forth arm will receive Prednisolone Acetate 1% with DSEK Fifth arm will Receive Dextenza with DMEK, Sixth arm will receive Prednisolone Acetate 1% with DMEK', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

Updated at

2023-07-24

1 organization

2 products

7 indications

Organization

Nicole Fram

Product

Dextenza

Indication

Corneal Edema

Indication