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Comparison of the Postoperative Use of Dextenza vs a Standard Regimen After PRK

NCT05587231 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-20

No results posted yet for this study

Summary

Naval Refractive Surgery Center proposes a prospective, single-site, randomized, non-FDA regulated clinical trial with bilateral commercial treatment for for PRK. Subjects will be randomized to receive one of two postoperative steroid regimens: Dextenza (a dexamethasone ophthalmic insert) or standard of care topical Fluorometholone. Subjects will be followed for 3 months after surgery. Investigators will use objective and subjective measures to assess potential differences in postoperative healing and pain.

This study will not be FDA-regulated. All study surgeries will be standard of care, with the exception of the addition of the Dextenza insert after the PRK procedure among subjects randomized to the Dextenza group.

Conditions

  • Steroid Ophthalmic Insert

Interventions

DRUG

Dextenza 0.4Mg Ophthalmic Insert

The experimental group will have the Dextenza Insert implanted immediately after surgery

DRUG

Topical Fluorometholone

Steroid drops will be administered by the subject according to the standard of care taper

Sponsors & Collaborators

  • Navy Medical Center San Diego

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Drug
Yes

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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 NCT05587231 on ClinicalTrials.gov