Comparison of emedastine 0.05% or nedocromil sodium 2% eye drops and placebo in controlling local reactions in subjects with allergic conjunctivitis.
OBJECTIVE
To assess the efficacy of nedocromil sodium 2% eye drops and emedastine difumarate 0.05% eye drops in controlling the ocular allergic reaction induced by conjunctival allergen challenge (CAC).


METHODS
Thirty subjects with a personal history of allergic conjunctivitis were enrolled (first visit). At the second visit each subject randomly received emedastine 0.05% or nedocromil 2% in one eye and placebo in the other eye. Five minutes after the medication the offending allergen was instilled in both eyes. Ocular redness and itching were evaluated according to a standardized scoring system at 3, 10 and 20-minute intervals after instillation of the allergen. After one week (third visit) the whole procedure was repeated using the placebo in the eye used as control during second visit and one of the trial drug that was not used at second visit in the other eye (either emedastine or nedocromil).


RESULTS
Emedastine 0.05% and nedocromil 2% eye drops were more effective than placebo in controlling ocular redness and itching (p<0.01). Emedastine was more effective (p<0.01) than nedocromil in alleviating redness and itching 3 and 10 minutes after application of the allergen.


CONCLUSIONS
Emedastine 0.05% appeared superior to nedocromil 2% in producing immediate relief when subjects with allergic conjunctivitis were exposed to the offending allergen.
Orfeo
V
V
Clinica Mediterranea, Ophthalmology Unit, Napoli, Italy. vincenzorfeo@tin.it
Vardaro
A
A
Lena
P
P
Mensitieri
I
I
Tracey
M
M
De Marco
R
R
D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000009:adverse effects; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D003233:Conjunctivitis, Allergic / Q000188:drug therapy* / Q000209:etiology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D017835:Nedocromil / Q000008:administration & dosage / Q000627:therapeutic use*; D009883:Ophthalmic Solutions; D012449:Safety
D000485:Allergens; D018926:Anti-Allergic Agents; D001562:Benzimidazoles; D006634:Histamine H1 Antagonists; D009883:Ophthalmic Solutions; D017835:Nedocromil; C043345:emedastine