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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237012
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Pam Lightfield, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020


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

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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


Contacts
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Contact: Pam Lightfield (262) 637-0500 ext 5677 plightfield@amazingeye.com

Locations
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United States, Wisconsin
The Eye Center of Racine Recruiting
Racine, Wisconsin, United States, 53405
Contact: Pam Lightfield    262-637-0500 ext 5677    plightfield@amazingeye.com   
Sponsors and Collaborators
The Eye Centers of Racine and Kenosha
Investigators
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Principal Investigator: Inder P Singh, M.D. President

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Responsible Party: Pam Lightfield, 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: January 29, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Dexamethasone
Dexamethasone acetate
Lubricant Eye Drops
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Pharmaceutical Solutions