Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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
Dry Eye Syndromes 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 16, 2019
Actual Primary Completion Date : December 30, 2021
Actual Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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 Name: 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




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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. ITRACE [ Time Frame: 1 month ]
    measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237012


Locations
Layout table for location information
United States, Wisconsin
The Eye Center of Racine
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
The Eye Centers of Racine and Kenosha
Investigators
Layout table for investigator information
Principal Investigator: Inder P Singh, M.D. President
Layout table for additonal information
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: January 22, 2020    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Dexamethasone
Lubricant Eye Drops
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Ophthalmic Solutions
Pharmaceutical Solutions