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

Sponsor
Grene Vision Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05143281
Collaborator
Ocular Therapeutix, Inc. (Industry)
50
1
3.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone 0.4 MG [Dextenza]
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 23, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexamethasone Ophthalmic Insert

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

Drug: Dexamethasone 0.4 MG [Dextenza]
Ophthalmic Intracanalicular Insert
Other Names:
  • Dextenza
  • Outcome Measures

    Primary Outcome Measures

    1. Anterior Chamber Cells [Assessed on Day 7]

      As measured by summed ocular inflammation score (0-4)

    2. Ocular Pain [Assessed on Day 7]

      As measured by ocular pain assessment numerical grading scale (0-10)

    Secondary Outcome Measures

    1. Mean change in BCVA [Assessed on Day -1, Day 7, Day 30]

      As measured by snellen VA

    2. Percentage with complete absence of pain [Assessed on Day -1, Day 1, Day 7, Day 30]

      As measured by ocular pain assessment numerical grading scale (0-10)

    3. Percentage with complete absence of cell [Assessed on Day -1, Day 1, Day 7, Day 30]

      As measured by summed ocular inflammation score (0-4)

    4. Physician ease of insertion and visualization [Assessed on Day 1]

      As measured by physician questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Grene Vision Group
    • Ocular Therapeutix, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Grene Vision Group
    ClinicalTrials.gov Identifier:
    NCT05143281
    Other Study ID Numbers:
    • SITE-2021-4001
    First Posted:
    Dec 3, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021