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
|