Trial | NCT04521140  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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 Started
Oct 16
2020
Primary Completion
Jan 04
2023
Study Completion
Jan 04
2023
Last Update
Jul 24
2023

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.

  • Other names: Dexamethasone Ophthalmic Insert

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

  • Other names: Omnipred, Pred Forte

PKP with Dextenza (study) Experimental

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

PKP without Dextenza (Controlled) Other

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

DSEK with Dextenza (study) Experimental

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

DSEK without Dextenza (Controlled) Other

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

DMEK with Dextenza (study) Experimental

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

DMEK without Dextenza (Controlled) Other

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

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
No Results Posted