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Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

NCT ID: NCT00133627

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-10-31

Brief Summary

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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

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Conditions

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Seasonal Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ketotifen

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sun Xinghuai

Role: PRINCIPAL_INVESTIGATOR

Hospital of Shanghai Medical University

Locations

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Hospital of Shanghai Medical University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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CZAD511ACN01

Identifier Type: -

Identifier Source: org_study_id