Trial | NCT04237012  Report issue

Title

ACCURATE Study for Subjects With Dry Eyes
Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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
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 Started
Dec 16
2019
Primary Completion
Dec 30
2021
Study Completion
Dec 30
2021
Last Update
Apr 28
2022

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

Other Over the counter Artificial tears

over the counter artificial tears PRN at patient discretion

Dextenza Experimental

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

Over the counter Artificial tears Active Comparator

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

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
No Results Posted