Back to resultsPatient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- 12 years of age or older.
- History (within the past 24 months) of allergic conjunctivitis.
- Active signs and symptoms of ocular allergies.
- Ocular health within normal limits, as determined by the investigator or subinvestigator.
- Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Contraindications or hypersensitivity to study medication or its components.
- One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
- Known history of recurrent corneal erosion syndrome.
- Ocular trauma or surgical intervention within 6 months prior to Visit 1.
- Participation in any other investigational study within 30 days before Visit 1.
- Pregnant or nursing.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Olopatadine 0.2%
Arm Description
1 drop self-administered in each eye once daily in the morning for 7 days
Outcomes
Primary Outcome Measures
Overall Patient Satisfaction
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
Overall Patient Satisfaction
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01159769
Brief Title
Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (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 is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.
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
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olopatadine 0.2%
Arm Type
Experimental
Arm Description
1 drop self-administered in each eye once daily in the morning for 7 days
Intervention Type
Drug
Intervention Name(s)
Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
Other Intervention Name(s)
Pataday®
Intervention Description
Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis
Primary Outcome Measure Information:
Title
Overall Patient Satisfaction
Description
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
Time Frame
Day 0
Title
Overall Patient Satisfaction
Description
Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12 years of age or older.
History (within the past 24 months) of allergic conjunctivitis.
Active signs and symptoms of ocular allergies.
Ocular health within normal limits, as determined by the investigator or subinvestigator.
Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Contraindications or hypersensitivity to study medication or its components.
One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
Known history of recurrent corneal erosion syndrome.
Ocular trauma or surgical intervention within 6 months prior to Visit 1.
Participation in any other investigational study within 30 days before Visit 1.
Pregnant or nursing.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis
We'll reach out to this number within 24 hrs