A comparison of the clinical efficacy of pheniramine maleate/naphazoline hydrochloride ophthalmic solution and olopatadine hydrochloride ophthalmic solution in the conjunctival allergen challenge model.

Abstract

BACKGROUND:

The signs and symptoms of allergic conjunctivitis include ocular redness and itching. Two treatment options currently indicated for acute ocular allergic reaction are pheniramine maleate 0.3%/naphazoline hydrochloride 0.025% ophthalmic solution, an over-the-counter antihistamine/vasoconstrictor combination; and olopatadine hydrochloride 0.1% ophthalmic solution, a prescription antihistamine/mast cell stabilizer.

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.

• 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)

Chemical References

• Allergens
• Anti-Allergic Agents
• Dibenzoxepins
• Drug Combinations
• Ophthalmic Solutions
• Pheniramine
• Olopatadine Hydrochloride
• Naphazoline

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)