Dextenza for Post-operative Treatment of Pterygium

NCT ID: NCT04351737

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2023-05-23

Brief Summary

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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

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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.

Conditions

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Pterygium of Both Eyes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pterygium patients

patients with bilateral pterytium

Group Type EXPERIMENTAL

Intracanalicular Dexamethasone, (0.4 mg) Insert

Intervention Type 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.

Prednisolone Acetate

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Prednisolone Acetate

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

Intervention Type DRUG

Other Intervention Names

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Dextenza

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brandon Eye Associates, PA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brandon Eye Associates

Brandon, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PERSIST Study

Identifier Type: -

Identifier Source: org_study_id

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