Official Title: “Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis”

Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Ketotifen

Inclusion Criteria:

• Age 3 years or older.
• History of seasonal allergic conjunctivitis
• Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:
• 1. at least intensity degree 2 for itching, and 2. at least intensity degree 4 for composite score of itching and conjunctival hyperaemia

Exclusion Criteria:

• Other systemic/ophthalmic conditions
• Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
• Active bacterial or viral conjunctivitis or history of ocular herpes.
• Presence or history of severe dry eye.
• Previous treatments
• Any systemic or ocular corticosteroids within two (2) weeks prior to randomization.
• Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization.
• Any other ophthalmic medication within three (3) days prior to randomization.
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Sun Xinghuai Principal Investigator Hospital of Shanghai Medical University  

Information obtained from ClinicalTrials.gov on January 07, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00133627

Study ID Number: CZAD511ACN01

ClinicalTrials.gov Identifier: NCT00133627

Health Authority: China: State Food and Drug Administration