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Dextenza for Post-operative Treatment of Pterygium

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04351737
Acronym
PERSIST
Enrollment
20
Registered
2020-04-17
Start date
2020-07-15
Completion date
2023-05-23
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium of Both Eyes

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.

Interventions

DRUGIntracanalicular 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.

DRUGPrednisolone Acetate

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

Sponsors

Brandon Eye Associates, PA
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

patients with bilateral pterygium -

Exclusion criteria

none \-

Design outcomes

Primary

MeasureTime frameDescription
Patient pain level follow pterygium removal2 monthsmeasurement 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.
inflammation2 monthsmeasurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026