Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Novartis

Status and phase

Completed

Phase 4

Conditions

Seasonal Allergic Conjunctivitis

Treatments

Drug: Ketotifen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00133627

CZAD511ACN01

Details and patient eligibility

About

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.

Enrollment

229 patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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