April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
Alcaftadine 0.25% Ophthalmic Solution Demonstrates Fast and Long-Lasting Efficacy in the Prevention of Ocular Itch
Author Affiliations & Notes
  • Paul J. Gomes
    Allergy, ORA, Andover, Massachusetts
  • Mark B. Abelson
    Allergy, ORA, Andover, Massachusetts
    Schepens Eye Research Institute, Harvard Medical School, Boston, Massachusetts
  • Donna Welch
    Allergy, ORA, Andover, Massachusetts
  • Gail Torkildsen
    Allergy, ORA, Andover, Massachusetts
  • Arthur Shedden
    Vistakon Pharmaceuticals, LLC, Jacksonville, Florida
  • Footnotes
    Commercial Relationships  Paul J. Gomes, None; Mark B. Abelson, None; Donna Welch, None; Gail Torkildsen, None; Arthur Shedden, I (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 6421. doi:
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      Paul J. Gomes, Mark B. Abelson, Donna Welch, Gail Torkildsen, Arthur Shedden; Alcaftadine 0.25% Ophthalmic Solution Demonstrates Fast and Long-Lasting Efficacy in the Prevention of Ocular Itch. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6421.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : A conjunctival allergen challenge (CAC) clinical study (NCT00889330) was performed to evaluate safety and efficacy of alcaftadine 0.25% ophthalmic solution, a new ocular antiallergy drug.

Methods: : This phase III, multi-center, two-arm, placebo-controlled trial enrolled volunteers 10 years of age and greater with a history of allergic conjunctivitis. Subjects were randomized to bilaterally receive either 1 drop of alcaftadine 0.25% ophthalmic solution or vehicle. After 16 hours (Visit 3) and 15 minutes (Visit 4), a CAC was performed and ocular and nasal symptoms of allergy were graded. Clinical and statistical significance were evaluated. The primary endpoints were ocular itching and conjunctival redness. Safety measures included visual acuity and slit lamp biomicroscopy, as well as adverse event reporting. A CAC was performed 16 hours and 15 minutes after instillation of test agent, and ocular and nasal symptoms of allergy were graded.

Results: : Alcaftadine was effective in the prevention of ocular itching based on clinically and statistically significant differences compared with vehicle. Alcaftadine significantly reduced conjunctival redness, and almost all other allergic signs and symptoms at both 15 minutes and 16 hours after drug administration. Measured at 3 minutes following each allergen challenge, the percentage of patients with minimal itch (defined as mean ocular itch score < 1) in the alcaftadine-treated groups were 97% (Visit 4, onset of action, 15 minutes) and 87 % (Visit 3, duration of action, 16 hours).

Conclusions: : Therefore, having demonstrated an onset of action within 3 minutes and a duration of action of at least 16 hours for the prevention of ocular itch, alcaftadine 0.25% is a valuable addition to the ocular allergy armamentarium.

Clinical Trial: : http://www.clinicaltrials.gov NCT00889330

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 

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