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History of Changes for Study: NCT04237012
ACCURATE Study for Subjects With Dry Eyes (ACCURATE)
Latest version (submitted April 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 17, 2020 None (earliest Version on record)
2 January 24, 2020 Outcome Measures and Study Status
3 January 27, 2020 Outcome Measures and Study Status
4 February 1, 2021 Study Status
5 April 21, 2022 Recruitment Status, Study Status, Contacts/Locations, Study Design and Sponsor/Collaborators
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Study NCT04237012
Submitted Date:  January 17, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: WIRB Protocol # 20192595
Brief Title: ACCURATE Study for Subjects With Dry Eyes (ACCURATE)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2020
Overall Status: Recruiting
Study Start: December 16, 2019
Primary Completion: December 30, 2020 [Anticipated]
Study Completion: December 30, 2020 [Anticipated]
First Submitted: January 13, 2020
First Submitted that
Met QC Criteria:
January 17, 2020
First Posted: January 22, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
January 17, 2020
Last Update Posted: January 22, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The Eye Centers of Racine and Kenosha
Responsible Party: Principal Investigator
Investigator: Pam Lightfield
Official Title: I. Paul Singh, M.D. Principal Investigator
Affiliation: The Eye Centers of Racine and Kenosha
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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
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.
Open or close this module Conditions
Conditions: Dry Eye Syndromes
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Over the counter Artificial tears
over the counter artificial tears PRN at patient discretion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Pam Lightfield
Telephone: (262) 637-0500 Ext. 5677
Email: plightfield@amazingeye.com
Study Officials: Inder P Singh, M.D.
Principal Investigator
President
Locations: United States, Wisconsin
The Eye Center of Racine
[Recruiting]
Racine, Wisconsin, United States, 53405
Contact:Contact: Pam Lightfield 262-637-0500 Ext. 5677 plightfield@amazingeye.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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