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Assessing Dextenza Insert After SMILE Procedure

NCT04380857 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-06

Study results available
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Summary

This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

Conditions

  • Post Procedural Infection

Interventions

DRUG

Dexamethasone ophthalmic insert 0.4 mg

intracanalicular dexamethasone insert

DRUG

Topical Prednisolone Acetate Ophthalmic Drops

Topical Prednisolone acetate ophthalmic drops per standard of care: Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue

Sponsors & Collaborators

  • William Wiley, MD

    lead OTHER

Principal Investigators

  • William Wiley, MD · Cleveland Eye Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2021-06-21
Completion
2021-06-21
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 NCT04380857 on ClinicalTrials.gov