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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
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis

Eligibility Criteria

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

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

First Posted
February 10, 2011
Last Updated
December 15, 2016
Sponsor
Alcon Research
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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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