NCT04351737

Dextenza for Post-operative Treatment of Pterygium

DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Brandon Eye Associates, PA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery

Detailed description

In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.

Conditions

• Pterygium of Both Eyes

Interventions

Type	Name	Description
DRUG	Intracanalicular Dexamethasone, (0.4 mg) Insert	To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery.
DRUG	Prednisolone Acetate	To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.

Timeline

• Start date: 2020-07-15
• Primary completion: 2022-07-15
• Completion: 2023-05-23
• First posted: 2020-04-17
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study