ACCURATE Study for Subjects With Dry Eyes

The Eye Centers of Racine and Kenosha

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Dextenza 0.4Mg Intracanalicular Insert; Other: Over the counter Artificial tears

Study type: Interventional

Funder types: Other

Identifiers

NCT04237012

WIRB Protocol # 20192595

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Dextenza

Experimental group

Description:

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

Treatment:

Drug: Dextenza 0.4Mg Intracanalicular Insert

Over the counter Artificial tears

Active Comparator group

Description:

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

Treatment:

Other: Over the counter Artificial tears