Dextenza for Post-operative Treatment of Pterygium

Phase 4

• Conditions: Pterygium of Both Eyes
• Interventions: Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert; Drug: Prednisolone Acetate

• Registration Number: NCT04351737
• Lead Sponsor: Brandon Eye Associates, PA

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Study Start: 2020-07-15
• Status Verified: 2022-07
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

patients with bilateral pterygium -

Exclusion Criteria

none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pterygium patients	Intracanalicular Dexamethasone, (0.4 mg) Insert	patients with bilateral pterytium
Pterygium patients	Prednisolone Acetate	patients with bilateral pterytium

Primary Outcome Measures

Name	Time	Method
Patient pain level follow pterygium removal	2 months	measurement of pain following pterygium removal using the validated "Numeric Pain Rating Scale" to assess pain, which ranges from 0 to 10 with higher values indicating more severe pain.
inflammation	2 months	measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.

Trial Locations

Locations (1)

Brandon Eye Associates; 🇺🇸 Brandon, Florida, United States