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Efficacy and safety of ketotifen fumarate 0.025% in the conjunctival antigen challenge model of ocular allergic conjunctivitis.

AbstractPURPOSE:
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.
AuthorsJack V Greiner, Thomas Mundorf, Harvey Dubiner, John Lonsdale, Richard Casey, Leonard Parver, Barry M Kapik, Naveed B K Shams, Mark B Abelson
JournalAmerican journal of ophthalmology (Am J Ophthalmol) Vol. 136 Issue 6 Pg. 1097-105 (Dec 2003) ISSN: 0002-9394 [Print] United States
PMID14644221 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Allergens
  • Anti-Allergic Agents
  • Antigens
  • Histamine H1 Antagonists
  • Ophthalmic Solutions
  • Ketotifen
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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