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Completed

NCT Number: NCT04237012

ACCURATE Study for Subjects With Dry Eyes

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

Completed

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Eye Center of Racine

Racine, Wisconsin, 53405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextenza 0.4Mg Intracanalicular Insert

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

Other names: dexamethasone

Over the counter Artificial tears

Other

over the counter artificial tears PRN at patient discretion

Primary outcomes

  1. Determine effect of dexamethasone insert over artificial tears

    Time frame: 1 month

    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

Secondary outcomes

  1. OSDI scores

    Time frame: 1 month

    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

Other outcomes

  1. ITRACE

    Time frame: 1 month

    measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any

  2. IOL Master

    Time frame: 1 month

    as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit

Sponsors and collaborators

Lead sponsor

The Eye Centers of Racine and Kenosha

Other

Registry information

Official study title

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

Acronym: ACCURATE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2020
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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