A Phase 4 interventional study of Intracanalicular Dexamethasone, (0.4 mg) Insert and Prednisolone Acetate in Pterygium of Both Eyes, sponsored by Brandon Eye Associates, PA. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Brandon Eye Associates, PA · Phase 4, Interventional, and Treatment
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
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.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →This is the only study on the registry with Brandon Eye Associates, PA as lead sponsor.
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Inclusion Criteria: patients with bilateral pterygium -
Exclusion Criteria: none
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patients with bilateral pterytium
Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert · Drug: Prednisolone Acetate
To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery.
Also known as: Dextenza
To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.
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.
Time frame: 2 months
inflammation
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Jul 2022, 24 months.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone