ACCURATE Study for Subjects With Dry Eyes

Phase 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Dextenza 0.4Mg Intracanalicular Insert; Other: Over the counter Artificial tears

• Registration Number: NCT04237012
• Lead Sponsor: The Eye Centers of Racine and Kenosha

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.

Study Timeline

• Study Start: 2019-12-16
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextenza	Dextenza 0.4Mg Intracanalicular Insert	Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed
Over the counter Artificial tears	Over the counter Artificial tears	Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert

Primary Outcome Measures

Name	Time	Method
Determine effect of dexamethasone insert over artificial tears	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 Outcome Measures

Name	Time	Method
OSDI scores	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

Trial Locations

Locations (1)

The Eye Center of Racine; 🇺🇸 Racine, Wisconsin, United States