A comparative trial of the safety and efficacy of 0.1 percent pemirolast potassium ophthalmic solution dosed twice or four times a day in patients with seasonal allergic conjunctivitis.

Abstract

PURPOSE:

To compare efficacy and safety between twice-daily and four-times-daily regimens of pemirolast 0.1% in allergic conjunctivitis patients.

METHODS:

This investigator-masked trial recruited 169 patients, with a positive skin prick test, +2 itching and hyperemia. Patients were randomized to two times daily (t.i.d.) or four times daily (q.i.d.) treatment during allergy season. Evaluation was at 0, 2 and 4 weeks, with itching and hyperemia at week 4 as the primary endpoints. Analysis used last observation carried forward (LOCF) and analysis of variance (ANOVA) for efficacy, factoring treatment and center variations. The basis of the statistical evaluation was to confirm parity between two treatments, via noninferiority hypothesis testing. A 95% confidence interval (CI) with an upper limit of < or = 0.5 was set to assess non-inferiority or to conclude if schedules were statistically similar.

RESULTS:

B.i.d. and q.i.d. baselines were similar, respectively, for itching (2.6 and 2.8) and hyperemia (2.3 and 2.2). Week 4 itching was statistically non-inferior between treatments (1 b.i.d. versus 0.8 q.i.d.), with a mean treatment difference of 0.17 (-0.13, 0.47, Delta < or = 0.5). Week 4 hyperemia was comparable (1.2 for b.i.d. versus 1.0 for q.i.d). Week 2 scores and mean change from baseline (weeks 2 and 4), patient diary data, and investigator assessments were comparable. Both regimens were well tolerated with no differences in adverse events were observed.

CONCLUSIONS:

B.i.d. dosing was statistically non-inferior to q.i.d. dosing with respect to itching and hyperemia. Both regimens were similarly well tolerated in allergic conjunctivitis patients.

• Authors: Petrus Gous, Auli Ropo
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 20 Issue 2 Pg. 139-50 (Apr 2004) ISSN: 1080-7683 [Print] United States
• PMID: 15117570 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Histamine Antagonists
• Ophthalmic Solutions
• Pyridines
• Pyrimidinones
• pemirolast

Topics

• Adolescent
• Adult
• Aged
• Child
• Conjunctivitis, Allergic (drug therapy)
• Drug Administration Schedule
• Female
• Histamine Antagonists (administration & dosage, adverse effects, therapeutic use)
• Humans
• Instillation, Drug
• Male
• Middle Aged
• Ophthalmic Solutions
• Prospective Studies
• Pyridines (administration & dosage, adverse effects, therapeutic use)
• Pyrimidinones (administration & dosage, adverse effects, therapeutic use)
• Seasons
• Treatment Outcome