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In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery (Prepare)

Primary Purpose

Cataract

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Topical Prednisolone
Sponsored by
Mitchel Ibach
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

  • Patients under the age of 18.
  • Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
  • Active infectious ocular or systemic disease.
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
  • Patients with known hypersensitivity to Dexamethasone.
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
  • Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.0.
  • Patients with a history of ocular inflammation or macular edema.
  • Patients with a pre-existing epiretinal membrane (ERM)
  • Patients with allergy or inability to receive intracameral antibiotic.
  • Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
  • Patients with a corticosteroid implant (i.e. Ozurdex).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A Dextenza

    Group B Topical Prednisolone

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean anterior chamber cell/flare score
    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
    Mean anterior chamber cell/flare score
    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
    Mean anterior chamber cell/flare score
    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
    Mean pain score
    Mean pain score measured by Visual Analog Score numerical grading scale 0-10
    Mean pain score
    Mean pain score measured by Visual Analog Score numerical grading scale 0-10
    Mean pain score
    Mean pain score measured by Visual Analog Score numerical grading scale 0-10
    Patient preference
    As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire

    Secondary Outcome Measures

    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
    Incidence of Cystoid Macular Edema (CME)
    Incidence of Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT)
    Physician Ease of Use
    Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit
    Eye Drop Burden
    Eye Drop Burden Questionnaire numerical grading scale of 1-5
    Eye Drop Burden
    Eye Drop Burden Questionnaire numerical grading scale of 1-5

    Full Information

    First Posted
    August 2, 2021
    Last Updated
    August 25, 2021
    Sponsor
    Mitchel Ibach
    Collaborators
    Ocular Therapeutix, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05023304
    Brief Title
    In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
    Acronym
    Prepare
    Official Title
    In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 23, 2021 (Anticipated)
    Primary Completion Date
    July 27, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mitchel Ibach
    Collaborators
    Ocular Therapeutix, Inc.

    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.
    Yes

    5. Study Description

    Brief Summary
    To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.

    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
    Crossover Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A Dextenza
    Arm Type
    Experimental
    Arm Title
    Group B Topical Prednisolone
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Dextenza 0.4Mg Ophthalmic Insert
    Intervention Description
    The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical Prednisolone
    Intervention Description
    Standard of care topical drop treatment
    Primary Outcome Measure Information:
    Title
    Mean anterior chamber cell/flare score
    Description
    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
    Time Frame
    post-op Day 1
    Title
    Mean anterior chamber cell/flare score
    Description
    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
    Time Frame
    post-op Day 7
    Title
    Mean anterior chamber cell/flare score
    Description
    Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
    Time Frame
    post-op Week 4.
    Title
    Mean pain score
    Description
    Mean pain score measured by Visual Analog Score numerical grading scale 0-10
    Time Frame
    post-op Day 1
    Title
    Mean pain score
    Description
    Mean pain score measured by Visual Analog Score numerical grading scale 0-10
    Time Frame
    post-op Day 7
    Title
    Mean pain score
    Description
    Mean pain score measured by Visual Analog Score numerical grading scale 0-10
    Time Frame
    post-op Week 4
    Title
    Patient preference
    Description
    As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire
    Time Frame
    post-op Week 4
    Secondary Outcome Measure Information:
    Title
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
    Description
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
    Time Frame
    postop Day 1
    Title
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
    Description
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
    Time Frame
    postop Day 7
    Title
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
    Description
    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
    Time Frame
    postop Week 4
    Title
    Incidence of Cystoid Macular Edema (CME)
    Description
    Incidence of Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT)
    Time Frame
    post-op Week 4
    Title
    Physician Ease of Use
    Description
    Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit
    Time Frame
    Day 0
    Title
    Eye Drop Burden
    Description
    Eye Drop Burden Questionnaire numerical grading scale of 1-5
    Time Frame
    post-op Day 7
    Title
    Eye Drop Burden
    Description
    Eye Drop Burden Questionnaire numerical grading scale of 1-5
    Time Frame
    post-op Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery. Willing and able to comply with clinic visits and study related procedures Willing and able to sign the informed consent form Exclusion Criteria: Patients under the age of 18. Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test). Active infectious ocular or systemic disease. Patients with active infectious ocular or extraocular disease. Patients actively treated with local or systemic immunosuppression including systemic corticosteroids. Patients with known hypersensitivity to Dexamethasone. Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.0. Patients with a history of ocular inflammation or macular edema. Patients with a pre-existing epiretinal membrane (ERM) Patients with allergy or inability to receive intracameral antibiotic. Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL Patients with a corticosteroid implant (i.e. Ozurdex).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Keeley Puls-Boever
    Phone
    605-361-3937
    Email
    keeley.puls@vancethompsonvision.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristin Dunne
    Phone
    6053613937
    Email
    kristin.dunne@vancethompsonvision.com

    12. IPD Sharing Statement

    Learn more about this trial

    In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

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