Abstract | BACKGROUND:
Ketotifen fumarate blocks histamine1 ( H1) receptors, stabilizes mast cells, and acts as an eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). OBJECTIVE: METHODS: This was a single-center, double-masked, randomized, placebo-controlled, contralateral-eye comparison, allergen challenge trial conducted in the United States. Subjects were randomized to receive ketotifen 0.025% in one eye and placebo in the other. At visits 1 and 2, allergen challenges were performed to determine the allergen concentration eliciting a qualifying reaction for each subject. At the 3 subsequent visits, subjects received 1 drop of ketotifen 0.025% ophthalmic solution in one eye and vehicle solution as placebo in the other eye 15 minutes (visit 3), 6 hours (visit 4), and 8 hours (visit 5) before allergen challenge. The primary efficacy measure was the subject's rating of itching at 3, 7, and 10 minutes after challenge. RESULTS: Of the 89 subjects randomly assigned to masked trial medication at visit 3, 72 completed the study. At visits 3, 4, and 5, mean itching scores were significantly better for ketotifen-treated eyes at all postchallenge time points, compared with placebo (P<.001). Also at visits 3, 4, and 5, ketotifen was statistically superior to placebo in reducing ocular hyperemia at all postchallenge time points (P<.05). CONCLUSIONS:
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Authors | Mark B Abelson, Matthew J Chapin, Barry M Kapik, Naveed B K Shams |
Journal | Archives of ophthalmology (Chicago, Ill. : 1960)
(Arch Ophthalmol)
Vol. 121
Issue 5
Pg. 626-30
(May 2003)
ISSN: 0003-9950 [Print] United States |
PMID | 12742839
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Allergens
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Ophthalmic Solutions
- Ketotifen
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Topics |
- Adult
- Aged
- Allergens
(adverse effects)
- Anti-Allergic Agents
(administration & dosage)
- Conjunctiva
(blood supply, drug effects)
- Conjunctivitis, Allergic
(chemically induced, physiopathology, prevention & control)
- Double-Blind Method
- Female
- Histamine H1 Antagonists
(administration & dosage)
- Humans
- Hyperemia
(prevention & control)
- Ketotifen
(administration & dosage)
- Male
- Middle Aged
- Models, Biological
- Ophthalmic Solutions
- Pruritus
(prevention & control)
- Safety
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