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ACCURATE Study for Subjects With Dry Eyes

Sponsor
The Eye Centers of Racine and Kenosha (Other)
Overall Status
Completed
CT.gov ID
NCT04237012
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
24.5
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management

Condition or Disease Intervention/Treatment Phase
  • Drug: Dextenza 0.4Mg Intracanalicular Insert
  • Other: Over the counter Artificial tears
 Phase 4

Detailed Description

This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease
Actual Study Start Date :
Dec 16, 2019
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dextenza

Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed

Drug: Dextenza 0.4Mg Intracanalicular Insert
all patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion
Other Names:
  • dexamethasone

    		•
    Active Comparator: Over the counter Artificial tears

    Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert

    Other: Over the counter Artificial tears
    over the counter artificial tears PRN at patient discretion

    Outcome Measures

    Primary Outcome Measures

    1. Determine effect of dexamethasone insert over artificial tears [1 month]

      To determine the effect of dexamethasone insert plus over-the-counter artificial tears prn compared to over the counter artificial tears prn from Baseline at Week 2 (at 8 am, 12 pm and 4 pm) as measured by iTrace and IOL Master 700: and comfort of dry eyes using the OSDI scale and reading scores

    Secondary Outcome Measures

    1. OSDI scores [1 month]

      comfort of dry eyes using the OSDI scale and reading scores, scores are from the SPEED questionnaire. scale from 0-3 0-Never 1- Sometime 2-Often 3-Constant for the symptoms

    Other Outcome Measures

    1. ITRACE [1 month]

      measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any

    2. IOL Master [1 month]

      as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria:A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

    • Age 18 years and older

    • Demonstrate objective signs of Ocular Surface Disease (OSD) or

    • Demonstrate symptoms of OSD determined by a standardized questionnaire

    • No other corneal pathology to create unknown variability

    Exclusion Criteria:A patient who meets any of the following criteria in either eye will be excluded from the study:

    • History of using topical steroids or other anti-inflammatory drops within 6 months of the study

    • History of corticosteroid implant (Ozurdex or Iluvien) or intravitreal steroid use for macular disease in last 12 months

    • History or current use of oral steroids or immunosuppressants

    • Active ocular infection

    • History of HSV

    • History corneal refractive surgery

    • Uncontrolled Glaucoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Eye Center of Racine Racine Wisconsin United States 53405

    Sponsors and Collaborators

    • The Eye Centers of Racine and Kenosha

    Investigators

    • Principal Investigator: Inder P Singh, M.D., President

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inder Paul Singh, M.D., I. Paul Singh, M.D. Principal Investigator, The Eye Centers of Racine and Kenosha
    ClinicalTrials.gov Identifier:
    NCT04237012
    Other Study ID Numbers:
    • WIRB Protocol # 20192595
    First Posted:
    Jan 22, 2020
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Dexamethasone
    Lubricant Eye Drops

    Study Results

    No Results Posted as of Apr 28, 2022