Back to resultsDextenza for Post-operative Treatment of Pterygium (PERSIST)
Primary Purpose
Pterygium of Both Eyes
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intracanalicular Dexamethasone, (0.4 mg) Insert
Prednisolone Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium of Both Eyes
Eligibility Criteria
Inclusion Criteria: patients with bilateral pterygium -
Exclusion Criteria: none
-
Sites / Locations
- Brandon Eye Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pterygium patients
Arm Description
patients with bilateral pterytium
Outcomes
Primary Outcome Measures
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.
inflammation
measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.
Secondary Outcome Measures
Full Information
NCT ID
NCT04351737
First Posted
March 11, 2020
Last Updated
July 19, 2022
Sponsor
Brandon Eye Associates, PA
1. Study Identification
Unique Protocol Identification Number
NCT04351737
Brief Title
Dextenza for Post-operative Treatment of Pterygium
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brandon Eye Associates, PA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium of Both Eyes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pterygium patients
Arm Type
Experimental
Arm Description
patients with bilateral pterytium
Intervention Type
Drug
Intervention Name(s)
Intracanalicular Dexamethasone, (0.4 mg) Insert
Other Intervention Name(s)
Dextenza
Intervention Description
To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate
Intervention Description
To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.
Primary Outcome Measure Information:
Title
Patient pain level follow pterygium removal
Description
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.
Time Frame
2 months
Title
inflammation
Description
measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with bilateral pterygium -
Exclusion Criteria: none
-
Facility Information:
Facility Name
Brandon Eye Associates
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dextenza for Post-operative Treatment of Pterygium
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