ACCURATE Study for Subjects With Dry Eyes (ACCURATE)

• ClinicalTrials.gov Identifier: NCT04237012
• Recruitment Status: Completed
• First Posted: January 22, 2020
• Last Update Posted: April 28, 2022
• Sponsor: The Eye Centers of Racine and Kenosha
• Information provided by (Responsible Party): Inder Paul Singh, M.D., The Eye Centers of Racine and Kenosha

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

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndromes	Drug: Dextenza 0.4Mg Intracanalicular Insert; Other: Over the counter Artificial tears	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 16, 2019
• Actual Primary Completion Date: December 30, 2021
• Actual Study Completion Date: December 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dextenza; Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed	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 Name: dexamethasone
Active Comparator: Over the counter Artificial tears; Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert	Other: Over the counter Artificial tears; over the counter artificial tears PRN at patient discretion

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Wisconsin

The Eye Center of Racine

Racine, Wisconsin, United States, 53405

Sponsors and Collaborators

The Eye Centers of Racine and Kenosha

Investigators

• Principal Investigator: Inder P Singh, M.D.; President

More Information

• Responsible Party: Inder Paul Singh, M.D., I. Paul Singh, M.D. Principal Investigator, The Eye Centers of Racine and Kenosha
• ClinicalTrials.gov Identifier: NCT04237012
• Other Study ID Numbers: WIRB Protocol # 20192595
• First Posted: January 22, 2020
• Last Update Posted: April 28, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dexamethasone; Lubricant Eye Drops; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Ophthalmic Solutions; Pharmaceutical Solutions