Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Phase 4

Completed

• Conditions: Seasonal Allergic Conjunctivitis

• Registration Number: NCT00133627
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-23
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Hospital of Shanghai Medical University; 🇨🇳 Shanghai, China