COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133627
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : November 17, 2011
Alcon Research
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Seasonal Allergic Conjunctivitis Drug: Ketotifen Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Study Start Date : April 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133627

Layout table for location information
Hospital of Shanghai Medical University
Shanghai, China
Sponsors and Collaborators
Alcon Research
Layout table for investigator information
Principal Investigator: Sun Xinghuai Hospital of Shanghai Medical University
Layout table for additonal information
Responsible Party: Novartis Identifier: NCT00133627    
Other Study ID Numbers: CZAD511ACN01
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011
Keywords provided by Novartis:
Additional relevant MeSH terms:
Layout table for MeSH terms
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents