title: Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials.
abstract: BACKGROUND
  The efficacy and safety of the once-daily topical ophthalmic solutions, alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.
  
  
  METHODS
  Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score<1) and zero itch (itch score=0) was also assessed.
  
  
  RESULTS
  A total of 284 subjects were enrolled in the two studies. At 3 min post-CAC and 16 h after treatment instillation, alcaftadine 0.25% achieved a significantly lower mean itch score compared with olopatadine 0.2% (0.50 vs. 0.87, respectively; P=0.0006). Alcaftadine demonstrated a significantly lower mean itch score over all time points compared with olopatadine (0.68 vs. 0.92, respectively; P=0.0390); both alcaftadine- and olopatadine-treated subjects achieved significantly lower overall mean ocular itching scores compared with placebo (2.10; P<0.0001 for both actives). Minimal itch over all time points was reported by 76.1% of alcaftadine-treated subjects compared with 58.1% of olopatadine-treated subjects (P=0.0121). Treatment with alcaftadine 0.25% and olopatadine 0.2% was safe and well tolerated; no serious adverse events were reported.
  
  
  CONCLUSIONS
  Once-daily alcaftadine 0.25% ophthalmic solution demonstrated greater efficacy in prevention of ocular itching compared with olopatadine 0.2% at 3 min post-CAC (primary endpoint), and over all time points, 16 h post-treatment instillation. Alcaftadine and olopatadine both provided effective relief compared with placebo and were generally well tolerated.
authors.affiliation: Total Eye Care, P. A., 6060 Primacy Parkway, Suite 200, Memphis, TN, 38119, USA, totaleyeresearch@mac.com.
authors.forename: Eugene B
authors.initials: EB
authors.lastname: McLaurin
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: Marsico
authors.forename: Stacey L
authors.initials: SL
authors.lastname: Ackerman
authors.forename: Joseph B
authors.initials: JB
authors.lastname: Ciolino
authors.forename: Julia M
authors.initials: JM
authors.lastname: Williams
authors.forename: Linda
authors.initials: L
authors.lastname: Villanueva
authors.forename: David A
authors.initials: DA
authors.lastname: Hollander
mesh_terms: D000328:Adult; D000485:Allergens; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001552:Benzazepines / Q000008:administration & dosage / Q000009:adverse effects; D003233:Conjunctivitis, Allergic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000069605:Olopatadine Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects; D009883:Ophthalmic Solutions; D063868:Patient Outcome Assessment; D011537:Pruritus / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000485:Allergens; D018926:Anti-Allergic Agents; D001552:Benzazepines; D007093:Imidazoles; D009883:Ophthalmic Solutions; D000069605:Olopatadine Hydrochloride; C557708:alcaftadine