NCT04403516

Dextenza in Pterygium Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Michelle Rhee MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)

Detailed description

In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.

Conditions

• Pterygium

Interventions

Type	Name	Description
DRUG	Dexamethasone Intracanalicular Insert, 0.4mg	To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.
DRUG	Prednisolone Acetate 1%	To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-08-05
• Completion: 2021-08-05
• First posted: 2020-05-27
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study