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

October 27, 2021 updated by: Joseph Kavanagh, MD

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

Not yet recruiting

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 (Anticipated)

50

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 Contact

  • Name: Joseph T Kavanagh, MD
  • Phone Number: 210-387-0363
  • Email: japlh4@gmail.com

Study Contact Backup

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects will be eligible for study participation if they:

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

Exclusion Criteria:

  • Subjects are not eligible for study participation if they:

    1. Have active infectious systemic disease
    2. Have active infectious ocular or extraocular disease
    3. Have unobstructed nasolacrimal duct in the study eye(s)
    4. Have known hypersensitivity to dexamethasone or are a known steroid responder
    5. Have a history of ocular inflammation or macular edema
    6. Are currently being treated with immunomodulating agents in the study eye(s)
    7. Are currently being treated with immunosuppressants and/or oral steroids
    8. Are currently being treated with corticosteroid implant (i.e. Ozurdex)
    9. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
    10. Have a history of complete punctal occlusion in one or both punctum
    11. Currently use topical ophthalmic steroid medications
    12. Are unwilling or unable to comply with the study protocol
    13. 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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone Ophthalmic Insert
Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD)
Drug: Dexamethasone 0.4 MG [Dextenza]
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)
Assessed on Day 7
Ocular Pain
Time Frame: Assessed on Day 7
As measured by ocular pain assessment numerical grading scale (0-10)
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
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)
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)
Assessed on Day -1, 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

Collaborators and Investigators

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

Sponsor

Joseph Kavanagh, MD

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 (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SITE-2021-4002

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.

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