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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine 0.2% | Experimental | 1 drop self-administered in each eye once daily in the morning for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®) | Drug | Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Day 0 |
| 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." | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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215 patients were enrolled. All patients received the same treatment.
Patients were recruited from 12 US study centers. Eligible patients having a history of allergic conjunctivitis and treated with protocol-specified anti-allergy medications for at least 7 days within 6 months prior to Visit 1 were enrolled. Investigators reviewed files to identify patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine 0.2% | 1 drop self-administered in each eye once daily in the morning for 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Olopatadine 0.2% | 1 drop self-administered in each eye once daily in the morning for 7 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | All subjects who used the study medication at least once (intent to treat). | Posted | Number | Percentage of Participants | Day 0 |
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| Primary | 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." | All subjects who used the study medication at least once (intent to treat). | Posted | Number | Percentage of Participants | Day 7 |
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Adverse events were collected for the duration of the study: 7 June 2010 to 7 August 2010.
This reporting group includes all subjects who used the study medication at least once (intent to treat). Subjects were queried about any symptoms that would suggest an adverse event with, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olopatadine 0.2% | 1 drop self-administered in each eye once daily in the morning for 7 days | 2 | 215 | 0 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Unrelated |
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| Colorectal cancer | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Unrelated |
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Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Alcon Research, Ltd. | 800-862-5266 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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