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. 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

Condition	Intervention	Phase
Seasonal allergic conjunctivitis	Drug: Ketotifen	Phase IV

Further Study Details: 

Ages Eligible for Study:  3 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Age 3 years or older.
2. History of seasonal allergic conjunctivitis

3. 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

1. Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
2. Active bacterial or viral conjunctivitis or history of ocular herpes.
3. Presence or history of severe dry eye.

Previous treatments

1. Any systemic or ocular corticosteroids within two (2) weeks prior to randomization.
2. Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization.
3. Any other ophthalmic medication within three (3) days prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply

Please refer to this study by ClinicalTrials.gov identifier  NCT00133627

Customer Information Novartis      001-8886448585 

China
      Hospital of Shanghai Medical University, Shanghai,  China; Recruiting

Study chairs or principal investigators

Sun Xinghuai,  Principal Investigator,  Hospital of Shanghai Medical University   

Study ID Numbers:  CZAD511ACN01; SFDA; IND: 2004L04104; IND serial number:; J0301722
Last Updated:  August 22, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133627
Health Authority: China: State Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23