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The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1

NCT05143281 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-07-06

No results posted yet for this study

Summary

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

Conditions

  • Cataract

Interventions

DRUG

Dexamethasone 0.4 MG [Dextenza]

Ophthalmic Intracanalicular Insert

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    collaborator INDUSTRY

  • Grene Vision Group

    lead OTHER

Principal Investigators

  • Anita Campbell, MD · Grene Vision Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2023-02-01
Completion
2023-02-01
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 NCT05143281 on ClinicalTrials.gov