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ACCURATE Study for Subjects With Dry Eyes (ACCURATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237012
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Inder Paul Singh, M.D., The Eye Centers of Racine and Kenosha

Tracking Information
First Submitted Date  ICMJE January 13, 2020
First Posted Date  ICMJE January 22, 2020
Last Update Posted Date April 28, 2022
Actual Study Start Date  ICMJE December 16, 2019
Actual Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
Determine effect of dexamethasone insert over artificial tears [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
OSDI scores [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 27, 2020)
  • ITRACE [ Time Frame: 1 month ]
    measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any
  • IOL Master [ Time Frame: 1 month ]
    as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACCURATE Study for Subjects With Dry Eyes
Official Title  ICMJE Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • 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 Name: dexamethasone
  • Other: Over the counter Artificial tears
    over the counter artificial tears PRN at patient discretion
Study Arms  ICMJE
  • Experimental: Dextenza
    Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed
    Intervention: Drug: Dextenza 0.4Mg Intracanalicular Insert
  • Active Comparator: Over the counter Artificial tears
    Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert
    Intervention: Other: Over the counter Artificial tears
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2021
Actual Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04237012
Other Study ID Numbers  ICMJE WIRB Protocol # 20192595
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Inder Paul Singh, M.D., The Eye Centers of Racine and Kenosha
Original Responsible Party Pam Lightfield, The Eye Centers of Racine and Kenosha, I. Paul Singh, M.D. Principal Investigator
Current Study Sponsor  ICMJE The Eye Centers of Racine and Kenosha
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Inder P Singh, M.D. President
PRS Account The Eye Centers of Racine and Kenosha
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP