ACCURATE Study for Subjects With Dry Eyes

The Eye Centers of Racine and Kenosha30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye Syndromes

Interventions

Dextenza 0.4Mg Intracanalicular InsertDRUG

all patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion

Over the counter Artificial tearsOTHER

over the counter artificial tears PRN at patient discretion

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Eye Center of Racine

Racine, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

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

Time frame: 1 month

Data from ClinicalTrials.gov

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