Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Seasonal Allergic Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133627
• Other study ID #: CZAD511ACN01
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2005
• Last updated: November 16, 2011
• Start date: April 2005
• Est. completion date: October 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Seasonal Allergic Conjunctivitis

Intervention

Drug:
• Ketotifen

Locations

Country	Name	City	State
China	Hospital of Shanghai Medical University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Alcon Research

Country where clinical trial is conducted

China,