Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

This study has been completed.

First Received on August 22, 2005. Last Updated on November 16, 2011 History of Changes

Sponsor:	Novartis
Collaborator:	Alcon Laboratories
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Cold and Cough Medicines Pinkeye

Drug Information available for: Histamine Ketotifen Ketotifen fumarate

U.S. FDA Resources

Further study details as provided by Novartis:

Enrollment:	229
Study Start Date:	April 2005
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

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

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00133627 History of Changes
Other Study ID Numbers:	CZAD511ACN01
Study First Received:	August 22, 2005
Last Updated:	November 16, 2011
Health Authority:	China: State Food and Drug Administration

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
Ketotifen
Antipruritics
Dermatologic Agents

Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on February 09, 2012