Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery (NCT04521140) | Clinical Trial Compass
CompletedPhase 4
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery
United States36 participantsStarted 2020-10-16
Plain-language 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%.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Mean change in pain score
Timeframe: Assessed on Day 1,7 and 30
2
Mean change in inflammation (Cell and Flare) scores