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ACCURATE Study for Subjects With Dry Eyes

NCT ID: NCT04237012

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2021-12-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dextenza

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

Group Type EXPERIMENTAL

Dextenza 0.4Mg Intracanalicular Insert

Intervention Type DRUG

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 tears

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

Group Type ACTIVE_COMPARATOR

Over the counter Artificial tears

Intervention Type OTHER

over the counter artificial tears PRN at patient discretion

Interventions

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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

Intervention Type DRUG

Over the counter Artificial tears

over the counter artificial tears PRN at patient discretion

Intervention Type OTHER

Other Intervention Names

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dexamethasone

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Eye Centers of Racine and Kenosha

OTHER

Sponsor Role lead

Responsible Party

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Inder Paul Singh, M.D.

I. Paul Singh, M.D. Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inder P Singh, M.D.

Role: PRINCIPAL_INVESTIGATOR

President

Locations

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The Eye Center of Racine

Racine, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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WIRB Protocol # 20192595

Identifier Type: -

Identifier Source: org_study_id