Status:
COMPLETED
Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis
Lead Sponsor:
Novartis
Collaborating Sponsors:
Alcon Research
Conditions:
Seasonal Allergic Conjunctivitis
Eligibility:
All Genders
3+ years
Phase:
PHASE4
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 all...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT00133627
Start Date
April 1 2005
End Date
October 1 2005
Last Update
November 17 2011
Active Locations (1)
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1
Hospital of Shanghai Medical University
Shanghai, China