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In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

NCT05023304 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-17

Study results available
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Summary

To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.

Conditions

  • Cataract

Interventions

DRUG

Dextenza 0.4Mg Ophthalmic Insert

The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.

DRUG

Topical prednisolone acetate

Standard of care topical drop regimen with four week taper

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    collaborator INDUSTRY

  • Vance Thompson Vision

    lead OTHER

Principal Investigators

  • Mitch Ibach, OD · Vance Thompson Vision

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2022-07-27
Completion
2022-10-01
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 NCT05023304 on ClinicalTrials.gov