Patient Perception Study for AL-4943A
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AL-4943A
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- History of allergic conjunctivitis within last 24 months
- Active signs and symptoms of ocular allergies
Exclusion Criteria:
- Severe or serious ocular condition, ocular surgical intervention, ocular infection
Sites / Locations
- Alcon Korea Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AL-4943A
Arm Description
One drop per day in both eyes
Outcomes
Primary Outcome Measures
Overall Patient satisfaction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294969
Brief Title
Patient Perception Study for AL-4943A
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergic conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-4943A
Arm Type
Experimental
Arm Description
One drop per day in both eyes
Intervention Type
Drug
Intervention Name(s)
AL-4943A
Intervention Description
Once daily topical ocular allergy medication used for 7 days
Primary Outcome Measure Information:
Title
Overall Patient satisfaction
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of allergic conjunctivitis within last 24 months
Active signs and symptoms of ocular allergies
Exclusion Criteria:
Severe or serious ocular condition, ocular surgical intervention, ocular infection
Facility Information:
Facility Name
Alcon Korea Ltd.
City
Seoul
ZIP/Postal Code
06181
Country
Korea, Republic of
12. IPD Sharing Statement
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Patient Perception Study for AL-4943A
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