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PREFERENTIAL Study

Primary Purpose

Cataract Surgery, Glaucoma Surgery

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Surgery

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years and older
  • Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole CDVA of at least 20/200 in both eyes
  • 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes

Exclusion Criteria:

  • Active or history of chronic or recurrent inflammatory eye disease in either eye
  • Ocular pain in either eye
  • Proliferative diabetic retinopathy in either eye
  • Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
  • Laser or incisional ocular surgery during the study period and 6 months prior in either eye
  • Systemic concomitant pain medication management with pharmacologic class of oxycodone

  • Systemic NSAID use

    o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days

  • Clinically significant macular edema (CSME)
  • History of cystoid macular edema in the study eye

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    DEXTENZA vs prednisolone acetate 1%)

    Arm Description

    Subjects will randomly receive Dextenza or prednisolone acetate 1% in the first eye after surgery. At the time of the second eye surgery, the other eye will receive the drug that the first eye did not receive. Subjects will receive both drugs during the course of the study and therefore there is only 1 ARM for this study.

    Outcomes

    Primary Outcome Measures

    Percent of patients who stated they preferred dexamethasone insert as measured by patient report
    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
    Percent of patients who stated they preferred topical prednisolone insert as measured by patient report
    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.

    Secondary Outcome Measures

    The incidence of AE
    The incidence of adverse events
    The severity of AE
    The severity of adverse events
    Resolution of inflammation
    Resolution of inflammation as defined as either 0 or 0.5 cells or less cells on post-surgical day 14 as measured by SUN scale in an unmasked fashion.
    Resolution of pain
    Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7
    Absence of cell flare at day 14
    Absence of cell flare at day 14
    Mean change in BCVA
    Mean change in BCVA
    Mean change in central retinal thickness as measured by OCT
    Mean change in central retinal thickness as measured by OCT
    Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
    Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
    Percent of patients with rebound inflammation
    Percent of patients with rebound inflammation

    Full Information

    First Posted
    September 21, 2020
    Last Updated
    November 16, 2021
    Sponsor
    Duke University
    Collaborators
    Ocular Therapeutix, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04563559
    Brief Title
    PREFERENTIAL Study
    Official Title
    Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minimally Invasive Glaucoma Surgery (MIGS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI decided not to open study
    Study Start Date
    November 2020 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University
    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.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.
    Detailed Description
    Eyes from 80 patients will be randomized in a 1:1 ratio to the assigned treatment, dexamethasone insert placed at the time of surgery, or topical prednisolone acetate 1% therapy prescribed on a tapering dose schedule post-operatively. Males and Females 18 years and older with 1)Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole corrected distance visual acuity (CDVA) of at least 20/200 in both eyes and 2) 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber Intraocular Len (IOL) combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes. Study visits will consist of eye exam with ocular photos from an Optical Coherence Tomography (OCT).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DEXTENZA vs prednisolone acetate 1%)
    Arm Type
    Other
    Arm Description
    Subjects will randomly receive Dextenza or prednisolone acetate 1% in the first eye after surgery. At the time of the second eye surgery, the other eye will receive the drug that the first eye did not receive. Subjects will receive both drugs during the course of the study and therefore there is only 1 ARM for this study.
    Intervention Type
    Drug
    Intervention Name(s)
    Dextenza 0.4Mg Ophthalmic Insert
    Intervention Description
    The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
    Intervention Description
    The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule
    Primary Outcome Measure Information:
    Title
    Percent of patients who stated they preferred dexamethasone insert as measured by patient report
    Description
    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
    Time Frame
    45 days post second surgery
    Title
    Percent of patients who stated they preferred topical prednisolone insert as measured by patient report
    Description
    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
    Time Frame
    45 days post second surgery
    Secondary Outcome Measure Information:
    Title
    The incidence of AE
    Description
    The incidence of adverse events
    Time Frame
    Up to 3 months
    Title
    The severity of AE
    Description
    The severity of adverse events
    Time Frame
    Up to 3 months
    Title
    Resolution of inflammation
    Description
    Resolution of inflammation as defined as either 0 or 0.5 cells or less cells on post-surgical day 14 as measured by SUN scale in an unmasked fashion.
    Time Frame
    Day 14 post surgery
    Title
    Resolution of pain
    Description
    Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7
    Time Frame
    Day 7 post surgery
    Title
    Absence of cell flare at day 14
    Description
    Absence of cell flare at day 14
    Time Frame
    Day 14 post surgery
    Title
    Mean change in BCVA
    Description
    Mean change in BCVA
    Time Frame
    Baseline, 3 months
    Title
    Mean change in central retinal thickness as measured by OCT
    Description
    Mean change in central retinal thickness as measured by OCT
    Time Frame
    Baseline, 3 months
    Title
    Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
    Description
    Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
    Time Frame
    28 days post surgery
    Title
    Percent of patients with rebound inflammation
    Description
    Percent of patients with rebound inflammation
    Time Frame
    Up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years and older Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole CDVA of at least 20/200 in both eyes 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes Exclusion Criteria: Active or history of chronic or recurrent inflammatory eye disease in either eye Ocular pain in either eye Proliferative diabetic retinopathy in either eye Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye Laser or incisional ocular surgery during the study period and 6 months prior in either eye Systemic concomitant pain medication management with pharmacologic class of oxycodone Systemic NSAID use o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days Clinically significant macular edema (CSME) History of cystoid macular edema in the study eye
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leon Herndon, MD
    Organizational Affiliation
    Duke Eye Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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