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Completed

NCT Number: NCT04351737

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

Completed

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Key information

Conditions

Pterygium of Both Eyes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brandon Eye Associates

Brandon, Florida, 33511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with bilateral pterygium -

Exclusion criteria

none

-

Treatment and study plan

Intracanalicular Dexamethasone, (0.4 mg) Insert

Drug

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

Prednisolone Acetate

Drug

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

Primary outcomes

  1. Patient pain level follow pterygium removal

    Time frame: 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.

  2. inflammation

    Time frame: 2 months

    measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation.

Sponsors and collaborators

Lead sponsor

Brandon Eye Associates, PA

Other

Registry information

Official study 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

Acronym: PERSIST

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 17, 2020
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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