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Dextenza in Pterygium Surgery

NCT04403516 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-06

No results posted yet for this study

Summary

DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)

Conditions

  • Pterygium

Interventions

DRUG

Dexamethasone Intracanalicular Insert, 0.4mg

To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.

DRUG

Prednisolone Acetate 1%

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

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    collaborator INDUSTRY

  • Michelle Rhee MD

    lead OTHER

Principal Investigators

  • Michelle K Rhee, MD · New York Eye Specialists

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-08-05
Completion
2021-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403516 on ClinicalTrials.gov