DEXTenSiVe: DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures

Sponsor
Brian Jerkins, MD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05116345
Collaborator
Ocular Therapeutix, Inc. (Industry)
30
1
2
24
1.3

Study Details

Study Description

Brief Summary

This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: DEXTENZA

a single intracanalicular dexamethasone (0.4 mg) insert

Drug: DEXTENZA
Intracanalicular Dexamethasone ophthalmic insert (0.4mg)
Other Names:
  • Dexamethasone (0.4mg) Insert
  • Active Comparator: Topical Dexamethasone Treatment

    Standard of care topical dexamethasone treatment through Month 2 dosing and tapering following: 6x/day week 1 4x/day weeks 2-4 2x/day weeks 5-8 Day of surgery dexamethasone ointment and patch will be applied post-surgically for overnight treatment and removed at post-operative day 1 visit in Group B eyes.

    Drug: Topical Dexamethasone
    topical dexamethasone drops

    Outcome Measures

    Primary Outcome Measures

    1. Mean change in intraocular pressure (IOP) [From baseline through month 6]

      mean change in intraocular pressure (IOP) from day of surgery and proportion of eyes requiring additional topical dexamethasone or anti-metabolite therapy over time

    Secondary Outcome Measures

    1. Mean change in best corrected visual acuity (BCVA) [From baseline through month 6]

      Mean change in BCVA using Snellen eye charts

    2. Mean change in Visual Field (MD) [From baseline through month 6]

      Mean change in Visual Field (MD) will be detected using a perimeter device. The patient looks into the perimeter at a center target. Only one eye is tested at a time. The eye not being tested is covered with an eye patch. Small, dim lights will flash in the device and the patient will press a button each time they see the light. The results will show if the patient has had any changes in their visual field.

    3. Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development [From baseline through month 6]

      Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development

    4. Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale [From baseline through month 6]

      Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale

    5. Time to resolution of anterior chamber (AC) cells and/or AC flare [From baseline through month 6]

      Time to resolution of anterior chamber (AC) cells and/or AC flare

    6. Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence) [From baseline through month 6]

      Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)

    7. Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.). [From baseline through month 6]

      Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.).

    8. Incidence and severity of adverse events [From baseline through month 6]

      Incidence and severity of adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Able to provide signed written consent prior to participation in any study-related procedures

    • Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery

    Exclusion Criteria:
    • Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit

    • Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)

    • Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit

    • Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study

    • Are pregnant or lactating female, or female of childbearing age using inadequate birth control method

    • Have participated in another investigational device or drug study within 30 days of the baseline visit

    • Anterior chamber cells present at time of enrollment

    • Known allergy to dexamethasone or prednisolone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamilton Eye Institute Memphis Tennessee United States 38103

    Sponsors and Collaborators

    • Brian Jerkins, MD
    • Ocular Therapeutix, Inc.

    Investigators

    • Principal Investigator: Brian Jerkins, MD, University of Tennessee Health Science Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Brian Jerkins, MD, Assistant Professor, University of Tennessee Health Science Center
    ClinicalTrials.gov Identifier:
    NCT05116345
    Other Study ID Numbers:
    • The DEXTenSiVe Study
    First Posted:
    Nov 11, 2021
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    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 Nov 11, 2021