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

July 5, 2023 updated by: Grene Vision Group

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) Compared to Insertion 1-day Post-op - The SITE Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, controlled study to evaluate 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.

There will be approximately 50 eyes with two groups:

Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.

Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.

Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Grene Vision Group
      • Wichita, Kansas, United States, 67212
        • Grene Vision Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects will be eligible for study participation if they:

Are an adult subject aged 65 years or older Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form

Exclusion Criteria:

  • Subjects are not eligible for study participation if they:

Have active infectious systemic disease Have active infectious ocular or extraocular disease Have unobstructed nasolacrimal duct in the study eye(s) Have known hypersensitivity to dexamethasone or are a known steroid responder Have a history of ocular inflammation or macular edema Are currently being treated with immunomodulating agents in the study eye(s) Are currently being treated with immunosuppressants and/or oral steroids Are currently being treated with corticosteroid implant (i.e. Ozurdex) Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye Have a history of complete punctal occlusion in one or both punctum Currently use topical ophthalmic steroid medications Are unwilling or unable to comply with the study protocol Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone Ophthalmic Insert Day of Surgery
Day of surgery, in OR placement
Drug: Dexamethasone 0.4 MG [Dextenza]
Ophthalmic Intracanalicular Insert
Other Names:
  • Dextenza
Experimental: Dexamethasone Ophthalmic Insert Day 1 Post Op
Day 1 Post-Op, In-office (HOPD)
Drug: Dexamethasone 0.4 MG [Dextenza]
Ophthalmic Intracanalicular Insert
Other Names:
  • Dextenza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior Chamber Cells
Time Frame: Assessed on Day 7
As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Assessed on Day 7
Ocular Pain
Time Frame: Assessed on Day 7
As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
Assessed on Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in BCVA
Time Frame: Assessed on Day -1, Day 7, Day 30
As measured by snellen VA
Assessed on Day -1, Day 7, Day 30
Physician ease of insertion and visualization
Time Frame: Assessed on Day 1
As measured by physician questionnaire
Assessed on Day 1
Percentage with complete absence of pain
Time Frame: Assessed on Day -1, Day 1, Day 7, Day 30
As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
Assessed on Day -1, Day 1, Day 7, Day 30
Percentage with complete absence of cell
Time Frame: Assessed on Day -1, Day 1, Day 7, Day 30
As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Assessed on Day -1, Day 1, Day 7, Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grene Vision Group

Collaborators

Ocular Therapeutix, Inc.

Investigators

  • Principal Investigator: Anita Campbell, MD, Grene Vision Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SITE-2021-4001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Dexamethasone 0.4 MG [Dextenza]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe