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Title Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
Therapeutic Area Dry Eye
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender All
Contact Nancy Gee
617 636 5489
More Information


This prospective, single center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of IDI on ameliorating the signs and symptoms of dry eye disease. The study aims to enroll 54 patients (36 Dextenza commercial formulation, 18 Collagen Plug) with DED.

Study Details

Inclusion Criteria

  • Symptoms of DED such as foreign body sensation, burning, itching, stinging for at least 6 months
  • Ocular Surface Disease Index (OSDI) score > 23
  • Two or more of the following objective signs:
    • Schirmer’s II test <10 mm at 5 minutes
    • Tear break-up time (TBUT) of <10 seconds in one eye
    • Corneal fluorescein staining of 4 (National Eye Institute grading scheme, 0-15) in at least one eye
    • Conjunctival lissamine green staining of the nasal and temporal conjunctiva ≥4 (National Eye Institute grading scheme, 0-18) in at least
    • one eye

Exclusion Criteria

  • History of diabetes
  • History of ocular surgery, corneal infection, or corneal injury within the last 3 months
  • Active ocular allergies, ocular infection or allergies to benzalkonium chloride “BAK” (an eye-drop preservative)

Study Requirements

3 visits: Screening, Baseline (which can be combined) and a follow up visit 1 month after.