Abstract | BACKGROUND: OBJECTIVE: This study was designed to compare, at onset of action, the relative effectiveness of pheniramine/ naphazoline and olopatadine, when administered before conjunctival allergen challenge (CAC), using the ocular allergy index (OAI) as the primary end point. METHODS: This was a prospective, randomized, double-masked, contralateral, active- and placebo-controlled, single-center study of the CAC model. The first 2 study visits established and confirmed the subjects' ocular allergic reaction (no medication administered). At visit 3, the subjects were randomly assigned to 1 of 3 contralateral (right eye vs left eye) treatment combinations: pheniramine/ naphazoline + olopatadine, pheniramine/ naphazoline + placebo, or olopatadine + placebo. Medication was given 10 minutes before CAC. The subjects' erythema in the ciliary, conjunctival, and episcleral vessel beds; eyelid swelling; chemosis; and itching were evaluated at 7, 12, and 20 minutes after CAC. The OAI was calculated as a composite score of 6 signs and symptoms of allergic conjunctivitis to assess global severity. Between-treatment differences in OAI scores were used to evaluate efficacy. Subjects were asked their eye drop preference at the conclusion of visit 3. RESULTS: Subjects (n = 83) ranged in age from 20 to 70 years (mean, 42.5 years), 61.4% (n = 51) were female, and 94.0% (n = 78) were white. Both pheniramine/ naphazoline and olopatadine were associated with significantly lower OAI scores than placebo at all 3 time points (all, P < 0.001). OAI scores were significantly lower with pheniramine/ naphazoline than with olopatadine at 12 and 20 minutes (P = 0.005 and P = 0.001, respectively). CONCLUSION: In this patient sample, studied in a CAC model of onset of action, prophylactic pheniramine/ naphazoline was more effective than olopatadine and placebo in alleviating the signs and symptoms of the acute ocular allergic reaction, as measured by the OAI.
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Authors | Jack V Greiner, Ira J Udell |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 27
Issue 5
Pg. 568-77
(May 2005)
ISSN: 0149-2918 [Print] United States |
PMID | 15978305
(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
- Dibenzoxepins
- Drug Combinations
- Ophthalmic Solutions
- Pheniramine
- Olopatadine Hydrochloride
- Naphazoline
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Topics |
- Administration, Topical
- Adult
- Aged
- Allergens
(immunology)
- Anti-Allergic Agents
(administration & dosage, therapeutic use)
- Conjunctivitis, Allergic
(drug therapy, immunology)
- Dibenzoxepins
(administration & dosage, therapeutic use)
- Double-Blind Method
- Drug Combinations
- Female
- Humans
- Male
- Middle Aged
- Naphazoline
(administration & dosage, therapeutic use)
- Olopatadine Hydrochloride
- Ophthalmic Solutions
- Pheniramine
(administration & dosage, therapeutic use)
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