search
Back to results

ACCURATE Study for Subjects With Dry Eyes (ACCURATE)

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza 0.4Mg Intracanalicular Insert
Over the counter Artificial tears
Sponsored by
The Eye Centers of Racine and Kenosha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Eye Center of Racine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dextenza

Over the counter Artificial tears

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2020
Last Updated
April 21, 2022
Sponsor
The Eye Centers of Racine and Kenosha
search

1. Study Identification

Unique Protocol Identification Number
NCT04237012
Brief Title
ACCURATE Study for Subjects With Dry Eyes
Acronym
ACCURATE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Eye Centers of Racine and Kenosha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextenza
Arm Type
Experimental
Arm Description
Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed
Arm Title
Over the counter Artificial tears
Arm Type
Active Comparator
Arm Description
Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert
Intervention Type
Drug
Intervention Name(s)
Dextenza 0.4Mg Intracanalicular Insert
Other Intervention Name(s)
dexamethasone
Intervention Description
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
Other
Intervention Name(s)
Over the counter Artificial tears
Intervention Description
over the counter artificial tears PRN at patient discretion
Primary Outcome Measure Information:
Title
Determine effect of dexamethasone insert over artificial tears
Description
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 Outcome Measure Information:
Title
OSDI scores
Description
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
Other Pre-specified Outcome Measures:
Title
ITRACE
Description
measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any
Time Frame
1 month
Title
IOL Master
Description
as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inder P Singh, M.D.
Organizational Affiliation
President
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Eye Center of Racine
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ACCURATE Study for Subjects With Dry Eyes

We'll reach out to this number within 24 hrs