Abstract | BACKGROUND: 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:
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Authors | M B Abelson |
Journal | Annals 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 |
PMID | 9759796
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Allergic Agents
- Dibenzoxepins
- Ophthalmic Solutions
- Olopatadine Hydrochloride
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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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