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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-16

Study Completion Date

2023-01-04

Brief Summary

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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%.

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Detailed Description

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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%.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

First 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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PKP with Dextenza (study)

Patients undergoing PKP will receive Dextenza insert with:

topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.

PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group Type EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type DRUG

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 Susp

Intervention Type DRUG

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

PKP without Dextenza (Controlled)

Patients undergoing PKP will receive:

topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.

PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group Type OTHER

Prednisolone Acetate 1% Oph Susp

Intervention Type DRUG

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

DSEK with Dextenza (study)

Patients undergoing DSEK will receive Dextenza insert with:

topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.

PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group Type EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type DRUG

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 Susp

Intervention Type DRUG

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

DSEK without Dextenza (Controlled)

Patients undergoing DSEK will receive:

topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.

PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group Type OTHER

Prednisolone Acetate 1% Oph Susp

Intervention Type DRUG

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

DMEK with Dextenza (study)

will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.

PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group Type EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type DRUG

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 Susp

Intervention Type DRUG

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

DMEK without Dextenza (Controlled)

Patients undergoing DMEK will receive:

topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter.

PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group Type OTHER

Prednisolone Acetate 1% Oph Susp

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Dexamethasone Ophthalmic Insert Omnipred, Pred Forte

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No