ACCURATE Study for Subjects With Dry Eyes

NCT04237012 | Completed Phase 4 FDA Drug

• 1 other identifier: WIRB Protocol # 20192595
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• OSDI scores

  1 month

Other Outcomes (2)

• ITRACE

  1 month

• IOL Master

  1 month

Study Arms (2)

Dextenza

EXPERIMENTAL

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

Over the counter Artificial tears

ACTIVE COMPARATOR

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

Other: Over the counter Artificial tears

Interventions

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

Also known as: dexamethasone

Dextenza

Over the counter Artificial tears OTHER

over the counter artificial tears PRN at patient discretion

Over the counter Artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Eye Centers of Racine and Kenosha: lead

Study Sites (1)

The Eye Center of Racine

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Inder P Singh, M.D.

  President

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: I. Paul Singh, M.D. Principal Investigator

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 22, 2020
• Study Start: December 16, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

US (1)