Dextenza for Post-operative Treatment of Pterygium

Pterygium of Both Eyes Clinical Trial

— PERSIST  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04351737
• Other study ID #: PERSIST Study
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 15, 2020
• Est. completion date: July 2022

Study information

• Verified date: July 2022
• Source: Brandon Eye Associates, PA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: patients with bilateral pterygium -

Exclusion Criteria: none

-

Related Conditions & MeSH terms

• Pterygium
• Pterygium of Both Eyes

Intervention

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

Locations

Country	Name	City	State
United States	Brandon Eye Associates	Brandon	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Brandon Eye Associates, PA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient pain level follow pterygium removal	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.	2 months
Primary	inflammation	measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.	2 months