ACCURATE Study for Subjects With Dry Eyes (ACCURATE)

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Dextenza 0.4Mg Intracanalicular Insert; Other: Over the counter Artificial tears

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: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Racine, Wisconsin, United States, 53405
      • The Eye Center of Racine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine effect of dexamethasone insert over artificial tears	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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI scores	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	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ITRACE	measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any	1 month
IOL Master	as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit	1 month

Collaborators and Investigators

• Sponsor: The Eye Centers of Racine and Kenosha
• Investigators: Principal Investigator: Inder P Singh, M.D., President

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Pharmaceutical Solutions; Ophthalmic Solutions; Dexamethasone; Lubricant Eye Drops
• Other Study ID Numbers: WIRB Protocol # 20192595

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No