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Evaluation of olopatadine, a new ophthalmic antiallergic agent with dual activity, using the conjunctival allergen challenge model.

AbstractBACKGROUND:
An ophthalmic antiallergic agent with selective H1 antihistaminic and mast cell stabilizing properties has been developed.
OBJECTIVES:
To evaluate efficacy and safety, determine optimal concentration, and demonstrate onset and duration of action of this new drug, olopatadine.
METHODS:
This was a placebo-controlled, randomized, double-masked, parallel-group, single-center study with five outpatient visits at least 7 days apart. Ninety-eight healthy, allergy-positive, subjects with a recent history of active allergic conjunctivitis not receiving current treatment participated. Conjunctival allergen challenge (CAC) tests were performed on visits 1 and 2 to identify an allergen and concentration that consistently elicited signs and symptoms of allergic conjunctivitis. On visits 3, 4, and 5, CAC was performed 27 minutes, 8 hours, and 6 hours, respectively, after instillation of one drop of olopatadine (0.01%, 0.05%, 0.1%, or 0.15%) in one eye and placebo in the other. Both eyes were scored for the intensity of itching and redness at 3, 10, and 20 minutes after the CAC.
RESULTS:
All four concentrations of olopatadine were clinically and statistically superior to placebo in preventing ocular itching at all evaluations and preventing redness at most evaluations from immediately and 8 hours after drug administration. No drug-related adverse events were reported. The 0.1% concentration was found to be most effective.
CONCLUSIONS:
The results indicate that olopatadine ophthalmic solution is safe and effective in the treatment of allergic conjunctivitis, with the 0.1% concentration of olopatadine being optimal. The rapid onset and at least 8 hour duration of action of olopatadine indicates that the drug can be used twice daily.
AuthorsM B Abelson
JournalAnnals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol) Vol. 81 Issue 3 Pg. 211-8 (Sep 1998) ISSN: 1081-1206 [Print] United States
PMID9759796 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Allergic Agents
  • Dibenzoxepins
  • Ophthalmic Solutions
  • Olopatadine Hydrochloride
Topics
  • Adult
  • Anti-Allergic Agents (therapeutic use)
  • Conjunctivitis, Allergic (drug therapy)
  • Dibenzoxepins (therapeutic use)
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Models, Immunological
  • Olopatadine Hydrochloride
  • Ophthalmic Solutions (administration & dosage)
  • Time Factors

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