Abstract | PURPOSE: To determine the duration of action of ketotifen 0.025% eye drops vs placebo taken as single or multiple doses in an allergen challenge model. DESIGN: Two randomized, multicenter, double-masked, contralateral placebo-controlled studies, one a single-dose and one a multiple-dose study. METHODS: Two conjunctival provocation tests (CPTs) were initially conducted to confirm reproducibility of subject responses in both studies. Subjects in study 1 (n = 87) received single doses of ketotifen in one eye and placebo in the other 15 minutes, 6 hours, and 8 hours before CPT. Subjects in study 2 (n = 85) received ketotifen or placebo once 8 hours before CPT. Single-dose efficacy results were used to further qualify a subject as a responder. Responders were re-randomized to a 4-week twice daily dosing regimen with a CPT 8 hours after the final dose. In both studies, ocular symptoms were assessed at three time points 3 to 15 minutes after challenge. There were no significant differences in adverse events between groups. RESULTS: For both studies, ocular itching and vascular injection were significantly reduced (P <.003) at all time points after instillation of ketotifen, with a maximum reduction at 7 minutes postchallenge. In study 2, chemosis, tearing, and lid swelling were also assessed and were significantly reduced (P <.008) after instillation of ketotifen. CONCLUSIONS:
Ketotifen 0.025% eye drops were safe and statistically effective in preventing ocular itching, injection, and other signs and symptoms of allergic conjunctivitis at 15 minutes, 6 hours, and 8 hours after a single dose and at 8 hours after the final dose of a 4-week twice daily regimen.
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Authors | Jack V Greiner, Thomas Mundorf, Harvey Dubiner, John Lonsdale, Richard Casey, Leonard Parver, Barry M Kapik, Naveed B K Shams, Mark B Abelson |
Journal | American journal of ophthalmology
(Am J Ophthalmol)
Vol. 136
Issue 6
Pg. 1097-105
(Dec 2003)
ISSN: 0002-9394 [Print] United States |
PMID | 14644221
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Allergens
- Anti-Allergic Agents
- Antigens
- Histamine H1 Antagonists
- Ophthalmic Solutions
- Ketotifen
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Topics |
- Adult
- Aged
- Allergens
(adverse effects)
- Anti-Allergic Agents
(administration & dosage)
- Antigens
(adverse effects)
- Conjunctiva
(blood supply, drug effects)
- Conjunctivitis, Allergic
(chemically induced, drug therapy)
- 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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