Efficacy and tolerability of ophthalmic epinastine: a randomized, double-masked, parallel-group, active- and vehicle-controlled environmental trial in patients with seasonal allergic conjunctivitis.
Abstract | BACKGROUND: OBJECTIVE: METHODS: This randomized (age-stratified), double-masked, parallel-group, active- and vehicle-controlled, environmental, Phase III clinical trial was conducted at 6 ophthalmology clinics in the United States. Patients aged >or=9 years diagnosed with SAC and who had a positive reaction in a conjunctival allergen challenge were enrolled. Patients were randomly assigned in a 2:2:1 ratio to receive 1 drop/eye BID of epinastine hydrochloride 0.05% ophthalmic solution, levocabastine hydrochloride 0.05% ophthalmic suspension, or vehicle of epinastine, respectively, for 8 weeks. The primary end point was ocular itching, and secondary end points included ocular hyperemia, chemosis, ocular mucous discharge (all assessed on a 5-point scale), eyelid swelling (assessed on a 4-point scale), and tearing (present or absent). Efficacy analyses used assessments from the two 1-week periods with the highest pollen counts. For tolerability assessment slit-lamp biomicroscopy and visual acuity examinations were conducted at each study visit (weeks 0, 2, 4, 6, and 8). RESULTS: Two-hundred ninety-eight patients (159 females, 139 males; mean [SD] age, 32.7 [14.6] years [range, 9-71 years]) entered the study; 118 received epinastine, 118 received levocabastine, and 62 received vehicle. Epinastine-treated patients reported significantly less ocular itching than those receiving vehicle (P=0.045); scores for hyperemia were similar between these 2 groups. Ocular itching and hyperemia scores were similar between the epinastine and levocabastine groups. No clinically or statistically significant between-group differences were seen in slit-lamp biomicroscopy findings, changes in visual acuity from baseline, or the incidence of treatment-related adverse effects. CONCLUSIONS:
|
Authors | Scott M Whitcup, Ron Bradford, John Lue, Rhett M Schiffman, Mark B Abelson |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 26
Issue 1
Pg. 29-34
(Jan 2004)
ISSN: 0149-2918 [Print] United States |
PMID | 14996515
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Dibenzazepines
- Histamine H1 Antagonists
- Imidazoles
- Ophthalmic Solutions
- Piperidines
- levocabastine
- epinastine
|
Topics |
- Adolescent
- Adult
- Aged
- Child
- Conjunctivitis, Allergic
(drug therapy)
- Dibenzazepines
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Histamine H1 Antagonists
(adverse effects, therapeutic use)
- Humans
- Imidazoles
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Ophthalmic Solutions
- Piperidines
(therapeutic use)
- Rhinitis, Allergic, Seasonal
(drug therapy)
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|