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

Primary Purpose

Cataract

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone 0.4 MG [Dextenza]
Sponsored by
Joseph Kavanagh, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dexamethasone Ophthalmic Insert

    Arm Description

    Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD)

    Outcomes

    Primary Outcome Measures

    Anterior Chamber Cells
    As measured by summed ocular inflammation score (0-4)
    Ocular Pain
    As measured by ocular pain assessment numerical grading scale (0-10)

    Secondary Outcome Measures

    Mean change in BCVA
    As measured by snellen VA
    Percentage with complete absence of pain
    As measured by ocular pain assessment numerical grading scale (0-10)
    Percentage with complete absence of cell
    As measured by summed ocular inflammation score (0-4)
    Physician ease of insertion and visualization
    As measured by physician questionnaire

    Full Information

    First Posted
    October 15, 2021
    Last Updated
    October 27, 2021
    Sponsor
    Joseph Kavanagh, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05100186
    Brief Title
    The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    February 28, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Joseph Kavanagh, MD

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone Ophthalmic Insert
    Arm Type
    Experimental
    Arm Description
    Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone 0.4 MG [Dextenza]
    Intervention Description
    Dextenza
    Primary Outcome Measure Information:
    Title
    Anterior Chamber Cells
    Description
    As measured by summed ocular inflammation score (0-4)
    Time Frame
    Assessed on Day 7
    Title
    Ocular Pain
    Description
    As measured by ocular pain assessment numerical grading scale (0-10)
    Time Frame
    Assessed on Day 7
    Secondary Outcome Measure Information:
    Title
    Mean change in BCVA
    Description
    As measured by snellen VA
    Time Frame
    Assessed on Day -1, Day 7, Day 30
    Title
    Percentage with complete absence of pain
    Description
    As measured by ocular pain assessment numerical grading scale (0-10)
    Time Frame
    Assessed on Day -1, Day 1, Day 7, Day 30
    Title
    Percentage with complete absence of cell
    Description
    As measured by summed ocular inflammation score (0-4)
    Time Frame
    Assessed on Day -1, Day 1, Day 7, Day 30
    Title
    Physician ease of insertion and visualization
    Description
    As measured by physician questionnaire
    Time Frame
    Assessed on Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joseph T Kavanagh, MD
    Phone
    210-387-0363
    Email
    japlh4@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anita Holland
    Phone
    210-387-0363
    Email
    japlh4@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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