Clinical evaluation of twice-daily emedastine 0.05% eye drops (Emadine eye drops) versus levocabastine 0.05% eye drops in patients with allergic conjunctivitis.
OBJECTIVE
The efficacy and safety of emedastine 0.05% eye drops (Emadine; Alcon Laboratories, Inc, Fort Worth, Texas), a new H(1) antagonist, were studied in comparison to levocabastine 0.05% eye drops (Livostin; Janssen-Cilag N V, Berchem, Belgium) during a twice-daily treatment schedule for 6 weeks in adult and pediatric patients with seasonal allergic conjunctivitis.


METHODS
In a prospective, multicenter, randomized, double-masked, parallel group study, 222 patients with allergic conjunctivitis were randomized (221 received treatment) to either emedastine or levocabastine, instilled twice daily for 6 weeks. Patient diaries were completed four times daily (before the morning and evening instillations, at noon, and in the afternoon), and clinical examinations were conducted at regular intervals. Primary efficacy variables of ocular redness and itching and secondary efficacy variables of chemosis, eyelid swelling, patient diary data, and physician's global assessment were analyzed.


RESULTS
Both emedastine and levocabastine produced a statistically significant (P =.0001) reduction in itching and redness within 5 minutes of the first instillation. All signs and symptoms improved progressively over the 6-week treatment period. After 7 days of use, and throughout the remainder of the study, emedastine was statistically superior to levocabastine (P <.006) in preventing and alleviating the signs and symptoms (itching, redness, chemosis, and eyelid swelling) of allergic conjunctivitis.


CONCLUSIONS
Emedastine 0.05% eye drops administered twice daily are more efficacious than levocabastine 0.05% eye drops in the prevention and treatment of the signs and symptoms of allergic conjunctivitis in adults and children of 4 years and above. Both emedastine 0.05% eye drops and levocabastine 0.05% eye drops were well tolerated.
Verin
P
P
Department of Ophthalmology, Centre Jean Abadie, 19 rue Thiac, Bordeaux, France.
Easty
D L
DL
Secchi
A
A
Ciprandi
G
G
Partouche
P
P
Nemeth-Wasmer
G
G
Brancato
R
R
Harrisberg
C J
CJ
Estivin-Ebrardt
C
C
Coster
D J
DJ
Apel
A J
AJ
Coroneo
M T
MT
Knorr
M
M
Carmichael
T R
TR
Kent-Smith
B T
BT
Abrantes
P
P
Leonardi
A
A
Cerqueti
P M
PM
Modorati
G
G
Martinez
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D011537:Pruritus
D001562:Benzimidazoles; D006634:Histamine H1 Antagonists; D009883:Ophthalmic Solutions; D010880:Piperidines; C043345:emedastine; C047340:levocabastine