Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

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.

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Key information

Conditions

Seasonal Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Eye Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of Shanghai Medical University

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketotifen

Drug

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

Alcon Research

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Aug 23, 2005
Registry last updated: Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed