PERSIST: Dextenza for Post-operative Treatment of Pterygium

Sponsor

Brandon Eye Associates, PA (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04351737

Collaborator

(none)

Enrollment

Location

Arm

23.5

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pterygium of Both Eyes	Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert Drug: Prednisolone Acetate	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model 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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pterygium patients patients with bilateral pterytium	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. Other Names: Dextenza Drug: Prednisolone Acetate To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.

Arm

Intervention/Treatment

Experimental: Pterygium patients

patients with bilateral pterytium

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.

Other Names:

Dextenza

Drug: Prednisolone Acetate

To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.

Outcome Measures

Primary Outcome Measures

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.