ACCURATE Study for Subjects With Dry Eyes

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Eye Centers of Racine and Kenosha
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Lubricant Eye Drops

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