title: Vehicle-Controlled, Phase 2 Clinical Trial of a Sustained-Release Dexamethasone Intracanalicular Insert in a Chronic Allergen Challenge Model.
abstract: To evaluate the efficacy and safety of a sustained-release dexamethasone intracanalicular insert (Dextenza™) in a model of allergic conjunctivitis.
  
  
  
  This was a randomized, double-masked, vehicle-controlled, Phase 2 study. Subjects had to have a positive conjunctival allergen challenge (CAC) reaction to allergen (bilateral +2 itching and redness on 5-point, 0-4 scales) at Visit 1, and for 2 of 3 time points on subsequent visits. Subjects who met entry criteria were randomized to receive Dextenza or PV (vehicle insert). Challenges occurred over 42 days, with efficacy assessed at 14 (primary endpoint visit), 28, and 40 days postinsertion. Outcome measures included the evaluation of ocular itching, redness, tearing, chemosis, eyelid swelling, rhinorrhea, and congestion.
  
  
  
  Twenty-eight subjects completed the study in the Dextenza group and 31 in the vehicle group. At 14 days postinsertion, Dextenza was statistically superior to PV, with least square mean differences for ocular itching of -0.76, -0.97, and -0.87 at 3, 5, and 7 min post-CAC, and for conjunctival redness of -0.46, -0.66, and -0.68 at 7, 15, and 20 min post-CAC. Clinical significance, defined as a 1-U decrease from PV, was not met for primary efficacy. Secondary endpoints, including number of subjects reporting itching and conjunctival redness, indicated superior performance of Dextenza compared with vehicle. Eleven Dextenza-treated (35.5%) and 10 vehicle-treated (30.3%) subjects each experienced a single adverse event.
  
  
  
  This Phase 2 study demonstrated preliminary efficacy and safety data of Dextenza for treatment of allergic conjunctivitis.
authors.affiliation: 1 Andover Eye Associates , Andover, Massachusetts.
authors.forename: Gail
authors.initials: G
authors.lastname: Torkildsen
authors.affiliation: 2 Department of Ophthalmology, Harvard Medical School , Boston, Massachusetts.|3 Ora, Inc. , Andover, Massachusetts.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Abelson
authors.affiliation: 3 Ora, Inc. , Andover, Massachusetts.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Gomes
authors.affiliation: 4 Total Eye Care , P.A., Memphis, Tennessee.
authors.forename: Eugene
authors.initials: E
authors.lastname: McLaurin
authors.affiliation: 5 Statistics and Data Corporation , Tempe, Arizona.
authors.forename: Susan L
authors.initials: SL
authors.lastname: Potts
authors.affiliation: 6 Scripps Clinic , La Jolla, California.
authors.forename: Francis S
authors.initials: FS
authors.lastname: Mah
mesh_terms: D060433:Administration, Ophthalmic; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D003907:Dexamethasone
keywords: Dextenza; allergy; conjunctivitis; corticosteroid; drug delivery; intracanalicular insert