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Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00133627
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : November 17, 2011
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Novartis

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

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





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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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


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 ClinicalTrials.gov identifier (NCT number): NCT00133627


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00133627     History of Changes
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:
Allergic
Conjunctivitis
Ketotifen
Histamine

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Ketotifen
Pharmaceutical Solutions
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents