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Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Conjunctivitis

Intervention: Ketotifen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Sun Xinghuai, Principal Investigator, Affiliation: Hospital of Shanghai Medical University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

Minimum age: 3 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hospital of Shanghai Medical University, Shanghai, China
Additional Information

Starting date: April 2005
Last updated: November 16, 2011

Page last updated: August 23, 2015

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