Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis
Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
  • Phase

    Phase 4
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    ketotifen ...
  • Study Participants

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 Started
Apr 30
Primary Completion
Oct 31
Study Completion
Oct 31
Last Update
Nov 17

Drug Ketotifen


Inclusion Criteria:

Age 3 years or older.
History of seasonal allergic conjunctivitis

Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:

at least intensity degree 2 for itching, and
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
No Results Posted