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Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Primary Purpose

Seasonal Allergic Conjunctivitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ketotifen
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Conjunctivitis focused on measuring Allergic, Conjunctivitis, Ketotifen, Histamine

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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

Sites / Locations

  • Hospital of Shanghai Medical University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 22, 2005
Last Updated
November 16, 2011
Sponsor
Novartis
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00133627
Brief Title
Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis
Official Title
Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
Collaborators
Alcon Research

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Conjunctivitis
Keywords
Allergic, Conjunctivitis, Ketotifen, Histamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ketotifen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Xinghuai
Organizational Affiliation
Hospital of Shanghai Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Shanghai Medical University
City
Shanghai
Country
China

12. IPD Sharing Statement

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Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

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