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Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis
This study has been completed.
Sponsors and Collaborators: Novartis
Alcon Laboratories
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00133627
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Conjunctivitis
Drug: Ketotifen
Phase IV

Drug Information available for: Ketotifen Ketotifen fumarate Histamine Histamine dihydrochloride Histamine phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

Further study details as provided by Novartis:

Study Start Date: April 2005
  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133627

Locations
China
Hospital of Shanghai Medical University
Shanghai, China
Sponsors and Collaborators
Novartis
Alcon Laboratories
Investigators
Principal Investigator: Sun Xinghuai Hospital of Shanghai Medical University
  More Information

Study ID Numbers: CZAD511ACN01
Study First Received: August 22, 2005
Last Updated: August 4, 2006
ClinicalTrials.gov Identifier: NCT00133627  
Health Authority: China: State Food and Drug Administration

Keywords provided by Novartis:
Allergic
Conjunctivitis
Ketotifen
Histamine

Study placed in the following topic categories:
Hypersensitivity
Ketotifen
Conjunctivitis, Allergic
Eye Diseases
Hypersensitivity, Immediate
Histamine phosphate
Conjunctivitis
Conjunctival Diseases
Histamine

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Histamine Agents
Histamine H1 Antagonists
Antipruritics
Anti-Allergic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009