Loading clinical trials...

Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

NCT00133627•Novartis

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - No limit years

Sex

ALL

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.

Locations (1)

Hospital of Shanghai Medical University

Shanghai, China

Key Dates

Start Date

April 1, 2005

Primary Completion Date

October 1, 2005

Completion Date

October 1, 2005

Last Updated

November 17, 2011

Enrollment

229

ACTUAL participants

Conditions

Seasonal Allergic Conjunctivitis

Interventions

Ketotifen

DRUG

Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis

NCT01541904

Ocular ItchingOcular Allergy+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions