ACCURATE Study for Subjects With Dry Eyes

Dry Eye Syndromes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237012
• Other study ID #: WIRB Protocol # 20192595
• Status: Completed
• Phase: Phase 4
• Start date: December 16, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: The Eye Centers of Racine and Kenosha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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

Other:
• Over the counter Artificial tears
over the counter artificial tears PRN at patient discretion

Locations

Country	Name	City	State
United States	The Eye Center of Racine	Racine	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Centers of Racine and Kenosha

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ITRACE	measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any	1 month
Other	IOL Master	as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit	1 month
Primary	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	1 month
Secondary	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	1 month