Back to resultsA Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- History (within the past 24 months) of allergic conjunctivitis.
- Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.
- Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Contraindications or hypersensitivity to the use of the study medication or its components.
- Inability or unwillingness to follow all study instructions and complete study visits as required.
- Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.
- A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
- Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pataday
Arm Description
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week
Outcomes
Primary Outcome Measures
Overall Patient Satisfaction
As assessed by the subject on a questionnaire
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01272089
Brief Title
A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Official Title
A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 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
The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pataday
Arm Type
Experimental
Arm Description
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week
Intervention Type
Drug
Intervention Name(s)
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Other Intervention Name(s)
Pataday
Intervention Description
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week
Primary Outcome Measure Information:
Title
Overall Patient Satisfaction
Description
As assessed by the subject on a questionnaire
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History (within the past 24 months) of allergic conjunctivitis.
Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.
Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Contraindications or hypersensitivity to the use of the study medication or its components.
Inability or unwillingness to follow all study instructions and complete study visits as required.
Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.
A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.
Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Kolkata
ZIP/Postal Code
700020
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
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