Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00133627

Collaborator

Alcon Research (Industry)

229

Enrollment

Location

Duration (Months)

38.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Apr 1, 2005

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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