NCT04521140

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%.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Nicole Fram M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Detailed description

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

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

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2020-10-16
• Primary completion: 2023-01-04
• Completion: 2023-01-04
• First posted: 2020-08-20
• Last updated: 2023-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study